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| [Code of Federal Regulations] |
| [Title 21, Volume 8] |
| [CITE: 21CFR890] |
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
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| PART 890 | PHYSICAL MEDICINE DEVICES |
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Subpart F - Physical Medicine Therapeutic Devices
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Sec. 890.5050 Daily activity assist device.
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(a) Identification. A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]
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Sec. 890.5100 Immersion hydrobath.
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(a) Identification. An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.
(b) Classification. Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]
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Sec. 890.5110 Paraffin bath.
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(a) Identification. A paraffin bath is a device intended for medical purposes that consists of a tub to be filled with liquid paraffin (wax) and maintained at an elevated temperature in which the patient's appendages (e.g., hands or fingers) are placed to relieve pain and stiffness.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]
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Sec. 890.5125 Nonpowered sitz bath.
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(a) Identification. A nonpowered sitz bath is a device intended for medical purposes that consists of a tub to be filled with water for use in external hydrotherapy to relieve pain or pruritis and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
[48 FR 53047, Nov. 23, 1983, as amended at 54 FR 25052, June 12, 1989; 66 FR 38818, July 25, 2001]
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Sec. 890.5150 Powered patient transport.
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(a) Powered patient stairway chair lifts - (1) Identification. A powered patient stairway chair lift is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.
(2) Classification. Class II. The stairway chair lift is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:
(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of American Society of Mechanical Engineers (ASME) A18.1 "Safety Standard for Platform Lifts and Stairway Chair Lifts") must demonstrate that the safety controls are adequate to prevent a free fall of the chair in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 "Safety Standard for Platform Lifts and Stairway Chair Lifts");
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, "Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests," and ASME A18.1 "Safety Standard for Platform Lifts and Stairway Chair Lifts") must validate electromagnetic compatibility and electrical safety; and
(v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.
(b) All other powered patient transport - (1) Identification. A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.
(2) Classification. Class II.
[78 FR 14017, Mar. 4, 2013]
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Sec. 890.5160 Air-fluidized bed.
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(a) Identification. An air-fluidized bed is a device employing the circulation of filtered air through ceramic spherules (small, round ceramic objects) that is intended for medical purposes to treat or prevent bedsores, to treat severe or extensive burns, or to aid circulation.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
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Sec. 890.5170 Powered flotation therapy bed.
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(a) Identification. A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
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Sec. 890.5180 Manual patient rotation bed.
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(a) Identification. A manual patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, or to aid circulation.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
[48 FR 53047, Nov. 23, 1963, as amended at 65 FR 2322, Jan. 14, 2000]
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Sec. 890.5225 Powered patient rotation bed.
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(a) Identification. A powered patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, urinary tract blockage, and to aid circulation.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
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Sec. 890.5250 Moist steam cabinet.
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(a) Identification. A moist steam cabinet is a device intended for medical purposes that delivers a flow of heated, moisturized air to a patient in an enclosed unit. It is used to treat arthritis and fibrosis (a formation of fibrosis tissue) and to increase local blood flow.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]
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Sec. 890.5275 Microwave diathermy.
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(a) Microwave diathermy for use in applying therapeutic deep heat for selected medical conditions - (1) Identification. A microwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the microwave frequency bands of 915 megahertz to 2,450 megahertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
(2) Classification. Class II (performance standards).
(b) Microwave diathermy for all other uses - (1) Identification. A microwave diathermy for all other uses except for the treatment of malignancies is a device that applies to the body electromagnetic energy in the microwave frequency bands of 915 megahertz to 2,450 megahertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.
(2) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any microwave diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to a microwave diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other microwave diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 64 FR 18331, Apr. 14, 1999]
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Sec. 890.5290 Shortwave diathermy.
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(a) Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions - (1) Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
(2) Classification. Class II (performance standards).
(b) Nonthermal shortwave therapy - (1) Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.
(2) Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:
(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 80 FR 61302, Oct. 13, 2015]
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Sec. 890.5300 Ultrasonic diathermy.
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(a) Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions - (1) Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
(2) Classification. Class II (performance standards).
(b) Ultrasonic diathermy for all other uses - (1) Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.
(2) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 64 FR 18331, Apr. 14, 1999]
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Sec. 890.5350 Exercise component.
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(a) Identification. An exercise component is a device that is used in conjunction with other forms of exercise and that is intended for medical purposes, such as to redevelope muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include weights, dumbbells, straps, and adaptive hand mitts.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38818, July 25, 2001]
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Sec. 890.5360 Measuring exercise equipment.
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(a) Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.
(b) Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019; 85 FR 44188, July 22, 2020]
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Sec. 890.5370 Nonmeasuring exercise equipment.
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(a) Identification. Nonmeasuring exercise equipment consist of devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a prone scooter board, parallel bars, a mechanical treadmill, an exercise table, and a manually propelled exercise bicycle.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38818, July 25, 2001]
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Sec. 890.5380 Powered exercise equipment.
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(a) Identification. Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a powered treadmill, a powered bicycle, and powered parallel bars.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]
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Sec. 890.5410 Powered finger exerciser.
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(a) Identification. A powered finger exerciser is a device intended for medical purposes to increase flexion and the extension range of motion of the joints of the second to the fifth fingers of the hand.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]
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Sec. 890.5420 Electroencephalography (EEG)-driven upper extremity powered exerciser.
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(a) Identification. An EEG-driven upper extremity powered exerciser is a non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient's brain.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must capture any adverse events observed during clinical use and must demonstrate that the EEG signal can be translated into intended motion.
(2) Software verification, validation, and hazard analysis must be performed.
(3) Performance data must demonstrate the electromagnetic compatibility, electrical safety, battery safety, and wireless compatibility of the device.
(4) The device components that contact the patient must be demonstrated to be biocompatible.
(5) Performance data must validate the reprocessing instructions for the reusable components of the device.
(6) Labeling must include:
(i) Instructions on fitting the device to the patient;
(ii) Information on how the device operates and the typical sensations experienced during treatment; and
(iii) Reprocessing instructions.
[88 FR 983, Jan. 6, 2023]
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Sec. 890.5500 Infrared lamp.
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(a) Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.
(b) Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]
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Sec. 890.5525 Iontophoresis device.
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(a) Iontophoresis device intended for certain specified uses - (1) Identification. An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body and induce sweating for use in the diagnosis of cystic fibrosis or for other uses if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug. When used in the diagnosis of cystic fibrosis, the sweat is collected and its composition and weight are determined.
(2) Classification. Class II (performance standards).
(b) Iontophoresis device intended for any other purposes - (1) Identification. An iontophoresis device intended for any other purposes is a prescription device that is intended to use a current to introduce ions of drugs or non-drug solutions into the body for medical purposes other than those specified in paragraph (a) of this section, meaning that the device is not intended for use in diagnosis of cystic fibrosis, or a specific drug is not specified in the labeling of the iontophoresis device.
(2) Classification. Class II (special controls). The device is classified as class II. The special controls for this device are:
(i) The following performance testing must be conducted:
(A) Testing using a drug approved for iontophoretic delivery, or a solution if identified in the labeling, to demonstrate safe use of the device as intended;
(B) Testing of the ability of the device to maintain a safe pH level; and
(C) If used in the ear, testing of the device to demonstrate mechanical safety.
(ii) Labeling must include adequate instructions for use, including sufficient information for the health care provider to determine the device characteristics that affect delivery of the drug or solution and to select appropriate drug or solution dosing information for administration by iontophoresis. This includes the following:
(A) A description and/or graphical representation of the electrical output;
(B) A description of the electrode materials and pH buffer;
(C) When intended for general drug delivery, language referring the user to drug labeling approved for iontophoretic delivery to determine if the drug they intend to deliver is specifically approved for use with that type of device and to obtain relevant dosing information; and
(D) A detailed summary of the device-related and procedure-related complications pertinent to use of the device, and appropriate warnings and contraindications, including the following warning:
Warning: Potential systemic adverse effects may result from use of this device. Drugs or solutions delivered with this device have the potential to reach the blood stream and cause systemic effects. Carefully read all labeling of the drug or solution used with this device to understand all potential adverse effects and to ensure appropriate dosing information. If systemic manifestations occur, refer to the drug or solution labeling for appropriate action.
(iii) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety.
(iv) Appropriate software verification, validation, and hazard analysis must be performed.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) The elements of the device that may contact the patient must be assessed for sterility, for devices labeled as sterile.
(vii) Performance data must support the shelf life of the elements of the device that may be affected by aging by demonstrating continued package integrity and device functionality over the stated shelf life.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 81 FR 48706, July 26, 2016; 83 FR 13864, Apr. 2, 2018]
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Sec. 890.5575 Powered external limb overload warning device.
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(a) Identification. A powered external limb overload warning device is a device intended for medical purposes to warn a patient of an overload or an underload in the amount of pressure placed on a leg.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]
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Sec. 890.5650 Powered inflatable tube massager.
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(a) Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.
(b) Classification. Class II (performance standards).
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Sec. 890.5660 Therapeutic massager.
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(a) Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]
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Sec. 890.5670 Internal therapeutic massager.
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(a) Identification. A hand-held internal therapeutic massager device is a prescription device intended for medical purposes to manually provide direct pressure applied to localized areas of pain or tenderness in the myofascial tissue associated with chronic pelvic pain syndromes. The device is inserted rectally or vaginally and provides quantitative feedback to the user of the applied force to the target tissue.
(b) Classification. Class II (special controls). The device, when it is for prescription use only with a quantitative feedback mechanism and a disposable covering, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9. The special controls for this device are:
(1) Labeling must include adequate directions for use.
(2) Non-clinical performance testing must demonstrate electromagnetic compatibility (EMC), electrical safety and mechanical safety.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Mechanical durability; and
(ii) Accuracy of the feedback mechanism.
(4) Software verification, validation, and hazard analysis must be performed.
(5) The patient-contacting components of the device must be demonstrated to be biocompatible.
[84 FR 57323, Oct. 25, 2019, as amended at 85 FR 44188, July 22, 2020]
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(a) Identification. A cold pack is a device intended for medical purposes that consists of a compact fabric envelope containing a specially hydrated pliable silicate gel capable of forming to the contour of the body and that provides cold therapy for body surfaces.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
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Sec. 890.5710 Hot or cold disposable pack.
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(a) Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.
(b) Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
[48 FR 53047, Nov. 23, 1963, as amended at 65 FR 2322, Jan. 14, 2000]
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Sec. 890.5720 Water circulating hot or cold pack.
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(a) Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
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Sec. 890.5730 Moist heat pack.
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(a) Identification. A moist heat pack is a device intended for medical purposes that consists of silica gel in a fabric container used to retain an elevated temperature and that provides moist heat therapy for body surfaces.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38818, July 25, 2001]
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Sec. 890.5740 Powered heating pad.
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(a) Identification. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
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Sec. 890.5760 Nonpowered lower extremity pressure wrap.
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(a) Identification. A nonpowered lower extremity pressure wrap is a prescription device that applies mechanical pressure by wrapping around the lower extremity, such as the leg or foot, and is intended for primary Restless Leg Syndrome.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
[79 FR 37950, July 3, 2014]
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Sec. 890.5765 Pressure-applying device.
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(a) Identification. A pressure-applying device is a device intended for medical purposes to apply continuous pressure to the paravertebral tissues for muscular relaxation and neuro-inhibition. It consists of a table with an adjustable overhead weight that, in place of the therapist's hands, presses on the back of a prone patient.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38818, July 25, 2001]
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Sec. 890.5800 Virtual reality behavioral therapy device for pain relief.
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(a) Identification. A virtual reality behavioral therapy device for pain relief is a device intended to provide behavioral therapy for patients with pain. Therapy is administered via a virtual reality display that utilizes a software program containing the behavioral therapy content.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Clinical performance testing under the labeled conditions for use must validate the model of behavioral therapy as implemented by the device and evaluate all adverse events.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Software verification, validation, and hazard analysis must be performed.
(4) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed.
(5) Labeling must include the following:
(i) A warning regarding the risk of nausea and motion sickness;
(ii) A warning regarding the risk of discomfort from the device; and
(iii) A summary of the clinical testing with the device.
[88 FR 985, Jan. 6, 2023]
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Sec. 890.5850 Powered muscle stimulator.
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(a) Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
(b) Classification. Class II (performance standards).
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Sec. 890.5860 Ultrasound and muscle stimulator.
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(a) Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions - (1) Identification. An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.
(2) Classification. Class II (performance standards).
(b) Ultrasound and muscle stimulator for all other uses - (1) Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.
(2) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 64 FR 18331, Apr. 14, 1999]
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Sec. 890.5880 Multi-function physical therapy table.
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(a) Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.
(b) Classification. Class II (performance standards).
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Sec. 890.5900 Power traction equipment.
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(a) Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.
(b) Classification. Class II (performance standards).
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Sec. 890.5925 Traction accessory.
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(a) Identification. A traction accessory is a nonpowered accessory device intended for medical purposes to be used with powered traction equipment to aid in exerting therapeutic pulling forces on the patient's body. This generic type of device includes the pulley, strap, head halter, and pelvic belt.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]
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Sec. 890.5940 Chilling unit.
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(a) Identification. A chilling unit is a refrigerative device intended for medical purposes to chill and maintain cold packs at a reduced temperature.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]
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Sec. 890.5950 Powered heating unit.
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(a) Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]
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Sec. 890.5975 Therapeutic vibrator.
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(a) Identification. A therapeutic vibrator is an electrically powered device intended for medical purposes that incorporates various kinds of pads and that is held in the hand or attached to the hand or to a table. It is intended for various uses, such as relaxing muscles and relieving minor aches and pains.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]
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Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.
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