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U.S. Department of Health and Human Services

List of Devices for Third Party Review

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Database updated: February 7, 2002

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This page lists devices currently eligible for third-party review under the FDA's Accredited Persons Program. Premarket notifications ["510(k)'s"] for devices on this list can be submitted to FDA-accredited third parties (Accredited Persons) in lieu of FDA. Information on the Accredited Persons Program, including links to this page and to a list of Accredited Persons, is available at the Accredited Persons Inspection Program website.

The following topics are discussed in this introduction to the list of eligible devices:

  • How to use the list of eligible devices
  • Some important exceptions to the list
  • Expansion pilot

How to Use the List of Eligible Devices

The list has five columns:

  • The first column provides the classification regulation number for each device from Title 21, Code of Federal Regulations (CFR), Parts 862-892. A classification regulation identifies a generic type of device and specifies the regulatory class that FDA has assigned to the device.
  • The second and third columns show the classification name for the device from the CFR, and the class of the device, respectively. In the second column, under each classification regulation name, one or more 3-letter product codes appear, along with the device name associated with each product code. Product codes represent specific subsets of devices grouped under the same classification regulation name. Manufacturers should determine the classification of their device at the product code level that most appropriately identifies their device(s).
  • The fourth column indicates if a device (product code) is included in the expansion pilot, described below, by showing the word "pilot." If this column is blank, the device is eligible for review under the pre-existing program and is not part of the expansion pilot.
  • The fifth column provides a link to device-specific guidance, if available, or to general guidance to assist manufacturers in the preparation-and Accredited Persons in the review-of 510(k)'s for eligible devices. Links are not provided for devices in the expansion pilot; device-specific guidance does not exist for these devices, and special procedures apply to the review of 510(k)'s for these devices by Accredited Persons, as discussed in FDA's January 2001 procedural guidance for the Accredited Persons Program, cited below.
Some Important Exceptions to the List

There are some exceptions that are not reflected in the eligible device list:

  • A device may be eligible even if it does not appear on the list if it is a Class I or Class II device that has been exempted from 510(k) by regulation, but requires a 510(k) because it exceeds the limitations of the exemption (as discussed in FDA's device classification regulations). Devices that are exempt from 510(k) are not shown on the list.
  • A Class II device on the list is ineligible if a 510(k) for the device requires clinical data to demonstrate substantial equivalence. This exception is discussed in FDA's procedural guidance for the Accredited Persons Program, cited below.
  • A device on the list is ineligible if a 510(k) for the device requires multi-Center review (e.g., 510(k)'s for drug/device combination products) or if a Center other than CDRH (e.g., the Center for Biologics Evaluation and Research) has primary responsibility for review.
Expansion Pilot

In an effort to encourage greater use of the Accredited Persons Program, FDA expanded the third party pilot to permit Accredited Persons to review many Class II devices that were not previously eligible. The expanded pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents. Information on the expansion pilot, including criteria allowing for the review of these Class II devices, can be found in the guidance document entitled Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties. Accredited Persons and other interested parties should refer to Section II.B., Purpose and Nature of the Program, for the criteria that would allow for the review of the Class II devices in the expansion pilot.


Physical Medicine

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Section No. Regulation Name
Product Code-Device Name
Class Pilot
Relevant
Guidance/Standard
890.1225 Chronaximeter. II  
  IKP -  Chronaximeter   Pilot  
890.1375 Diagnostic electromyograph. II  
  KZM -  Device, Muscle Monitoring   Pilot  
  IKN -  Electromyograph, Diagnostic   Pilot  
890.1385 Diagnostic electromyograph needle electrode. II  
  IKT -  Electrode, Needle, Diagnostic Electromyograph      
890.1450 Powered reflex hammer. II  
  IKO -  Hammer, Reflex, Powered   Pilot  
890.1850 Diagnostic muscle stimulator. II  
  ISB -  Stimulator, Muscle, Diagnostic   Pilot  
890.3110 Electric positioning chair. II  
  INO -  Chair, Positioning, Electric   Pilot  
890.3690 Powered wheeled stretcher. II  
  INK -  Stretcher, Wheeled, Powered   Pilot  
890.3800 Motorized three-wheeled vehicle. II  
  INI -  Vehicle, Motorized 3-Wheeled      
890.3850 Mechanical wheelchair. I  
  IOR -  Wheelchair, Mechanical      
  LBE -  Stroller, Adaptive      
890.3860 Powered wheelchair. II  
  ITI -  Wheelchair, Powered      
890.3880 Special grade wheelchair. II  
  IQC -  Wheelchair, Special Grade      
890.3900 Standup wheelchair. II  
  IPL -  Wheelchair, Standup      
890.3930 Wheelchair elevator. II  
  ING -  Elevator, Wheelchair, Portable   Pilot  
890.5100 Immersion hydrobath. II  
  ILJ -  Bath, Hydro-Massage      
  ILM -  Bath, Sitz, Powered      
890.5110 Paraffin bath. II  
  IMC -  Bath, Paraffin   Pilot  
890.5150 Powered patient transport. II  
  ILK -  Transport, Patient, Powered   Pilot  
890.5250 Moist steam cabinet. II  
  IMB -  Cabinet, Moist Steam   Pilot  
890.5275 Microwave diathermy. II  
  IOA -  Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat   Pilot  
890.5290 Shortwave diathermy. II  
  IMJ -  Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat   Pilot  
890.5300 Ultrasonic diathermy. II  
  IMI -  Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat   Pilot  
890.5360 Measuring exercise equipment. II  
  ISD -  Exerciser, Measuring   Pilot  
890.5500 Infrared lamp. II  
  ILY -  Lamp, Infrared, Therapeutic Heating      
  IOB -  Lamp, Infrared, Non Heating      
890.5525 Iontophoresis device. II  
  KTB -  Device, Iontophoresis, Specific Uses   Pilot  
890.5575 Powered external limb overload warning device. II  
  IRN -  Device, Warning, Overload, External Limb, Powered   Pilot  
890.5650 Powered inflatable tube massager. II  
  IRP -  Massager, Powered Inflatable Tube   Pilot  
890.5710 Hot or cold disposable pack. I  
  IMD -  Pack, Hot Or Cold, Disposable      
  MPO -  Infant Heel Warmer (Chemical Heat Pack)      
890.5850 Powered muscle stimulator. II  
  NUW -  Stimulator, Muscle, Powered, Dental   Pilot  
  IPF -  Stimulator, Muscle, Powered      
890.5860 Ultrasound and muscle stimulator. II  
  IMG -  Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat   Pilot  
890.5880 Multi-function physical therapy table. II  
  JFB -  Table, Physical Therapy, Multi Function   Pilot  
890.5900 Power traction equipment. II  
  ITH -  Equipment, Traction, Powered   Pilot  

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