Import Alert 80-06

Import Alert # 80-06

Published Date: 12/28/2021

Type: DWPE

"Detention Without Physical Examination of Medical Devices with False or Misleading Labeling"

Note: Revision of this Import Alert dated 08/25/2020 updates the Import Alert Name, the subtype to “Firm Alert”, the reason for the alert, the Guidance section to reflect current terminology and to add guidance, updates the contact information, and product description. Changes are bracketed by asterisks (***).

***The Food and Drug Administration has warned and/or taken action against a number of companies that have made improper claims about their products’ intended use. Some may carry significant health risks.

Section 502(a) declares that a drug or device is misbranded if its labeling proves false or misleading in any particular. Section 201(n) states that if an article is alleged to be misbranded because the labeling or advertising is misleading. Then, in determining whether the labeling or advertising is misleading, there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.***

*** Divisions may detain, without physical examination, shipments of the products identified on the Red List of this Alert.

A recommendation for addition to detention without physical examination and background information should be forwarded to DIO. DIO will coordinate a review of all recommendations for addition to detention without physical examination with CDRH Imports and Registration and Listing Team.***

The following devices are excluded from coverage under this Import Alert and any investigation of such devices should not be included:

a. Devices intended exclusively for use upon animals (non-human), check with the Center for Veterinary Medicine.

b. Prescription devices, which are being marketed as such.

***Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List, information should be provided to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or, be sent via email to: Importalerts2@fda.hhs.gov

DIO will coordinate the evaluation of a request for removal from detention without physical examination with CDRH Imports and Registration and Listing Team.

Questions involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at oraoismdssimpcomplsysbr@fda.hhs.gov

Questions concerning these types of devices or other compliance issues, should be addressed to the CDRH Imports and Registration & Listing Team via email: CDRH Import Mailbox cdrhimport@fda.hhs.gov ***

**All medical devices***

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device which is misbranded in that its labeling is false or misleading." [Misbranding, Section 502(a)]

OASIS charge code – FALSE

Desc: Bio-electric field enhancement unit (EEFE)

Notes: Relief of arthritis; muscular aches & pains allergies; incontinence; etc. 8/30/2000

Desc: Auricular candles with Otoska oil

Notes: Effective in treatment of ear wax build up; hearing problems; sinus congestion; frequent migraines and earaches. 4/3/96

Desc: Ear candles

Notes: Promotes better hearing; better lymphatic circulation; pressure regulation; etc. 2/5/1997

Desc: Auricular candles with oil - Oil manufacturer

Notes: Effective in treatment of ear wax build up; hearing problems; sinus congestion; frequent migraines and earaches. 4/3/96

Notes: Metal circular bowl entitled the "SUPERCONDUCTOR" Any therapeutic claims including but not limited to diabetes, leukemia,meningitis, multiple sclerosis, and tuberculosis.

Notes: Liver detoxification; pancreatic cancer detoxification; relief from migraines                           

Desc: Ear candles

Notes: Promotes better hearing; better lymphatic circulation; pressure regulation; etc. 2/5/1997

Desc: Electro Physiological Feedback Xrroid (EPFX) software (CLASP32 MASTER Program) and accessories

Notes: The firm's website contains statements which represent or suggest that the device is adequate and effective. The representations or suggestions are false or misleading or otherwise contrary to fact because the device is not adequate or effective for stated purposes; 09/24/08

Desc: Prolene sutures

Notes: Counterfeit- Package labeling may indicate manufactured by Ethicon 11/8/2005

Desc: Prolene sutures

Notes: Counterfeit- Package labeling may indicate manufactured by Ethicon 11/8/2005

Desc: Ceramic magnetic cup

Notes: 5/16/1994

Desc: Supernatural Hand Super Low Frequency Massager NM-166

Notes: 5/9/1997

Desc: Magnietic drinking cup

Notes: 3/29/1994

Desc: Revitalizes and rejuvenates the skin

Notes: Claims

Desc: Laser Light Applicator

Notes: Claims; Revitalizes and rejuvenates the skin

Desc: Laser Light Applicator

Notes: Claims; Revitalizes and rejuvenates the skin.

Desc: Laser Light Applicator

Notes: Claims; Revitalizes and rejuvenates the skin

Desc: Electro physiological feedback Xrroid (EPFX); Quantum Xrroid Consciousness Interface (QXCI) and accessories; Scientific Consciousness Interface Operations System (SCIO);Virtual Reality Imagery (VRI); Ascultacardiogram; CLASP 32 Master Program 1 CD; CLASP 32 Master Program 2 CD; Living Information Forms Energy (L.I.F.E) System

Notes: "bio-energetic medicine" for the treatment of disease or adverse medical conditions.The EPFX has a premarket notification for therapeutic biofeedback to control stress and to teach a patient to relax. The EPFX was not given marketing clearance for evoked potential biofeedback technology; to read the client¿s subtle energy fields; for electro-dermal screening; or for measuring the physical; mental; and emotional levels. 1/4/2008

Desc: Ethicon Prolene Mesh II

Notes: Counterfeit-Packaging may show ethicon logo printed in Copper plate rather than Helvetica & pouch lacks single piece of adhesive backing 2/10/2004

Desc: Laser Toothbrush

Notes: Class II. DWPE Date; 11/22/2011

Desc: Laser Toothbrush

Notes: Class II. DWPE Date; 11/22/2011

Notes: *All devices                                                                                                                                                                                                                                                                                                                                                                                                                                                     

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Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

Desc: ENART TENS Devices

Notes: Product declared as "VIBROMASSAGER" and labeled as a "BIOFEEDBACK" device with indications for use that require 510(k) clearance. Product lacks registration, listing, and 510(k) clearance. Claims related to disorders of the Central Nervous System; the Peripheral Nervous System; the respiratory system; etc.; as well as dental diseases. Published 2/6/2008.

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Desc: Omnivir Device (oxygen generator)

Notes: The device is also misbranded under Section 502(a) 21 U.S.C. 352(a) in that the labeling for the Omnivir device contains statements which represent or suggest that the device is adequate and effective to, "Fight HIV/AIDS and related opportunistic infections and protecting the immune system," which representations or suggestions are false or misleading or otherwise contrary to fact because the device is not adequate or effective for such purposes. The Omnivir device is also misbranded under section 502(j) of the Act, 21 U.S.C. 352(j), in that the device is dangerous to health when used in the manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof. 12/17/2008.

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002