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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 November 29, 2021

This page lists devices currently eligible for third-party review under the FDA's 510(k) Third Party Review Program, formally, the Accredited Persons Program. Premarket Notifications ["510(k)'s"] for devices on this list can be submitted to FDA-recognized 3P510K Review Organizations (Accredited Persons) in lieu of FDA. Information on the 510(k) Third Party Review Program, including links to this page and to a list of accredited persons, is available at the 510(k) Third Party Review Program website.

How to use the list of eligible devices

The list has four 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 provides a link to available standards to assist manufacturers in the preparation-and 3P510k review organizations in the review-of 510(k)s for eligible devices.

Some important exceptions to the list

Please see the 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations for exceptions to the list.


Physical Medicine

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Section No. Regulation Name
Product Code-Device Name
Class
Available
Standards
890.1225 Chronaximeter. II  
  IKP -  Chronaximeter  
890.1375 Diagnostic electromyograph. II  
  KZM -  Device, Muscle Monitoring  
  IKN -  Electromyograph, Diagnostic  
890.1385 Diagnostic electromyograph needle electrode. II  
  IKT -  Electrode, Needle, Diagnostic Electromyograph  
890.1850 Diagnostic muscle stimulator. II  
  ISB -  Stimulator, Muscle, Diagnostic  
890.3690 Powered wheeled stretcher. II  
  INK -  Stretcher, Wheeled, Powered  
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  
890.5150 Powered patient transport. II  
  ILK -  Transport, Patient, Powered  
890.5275 Microwave diathermy. II  
  IOA -  Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat  
890.5290 Shortwave diathermy. II  
  IMJ -  Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat  
890.5300 Ultrasonic diathermy. II  
  IMI -  Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat  
  PFW -  Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat  
890.5500 Infrared lamp. II  
  NHH -  Device, Discharge, Electrostatic (For Pain Relief)  
  IOB -  Lamp, Infrared, Non Heating  
  LBG -  Device, Fluidized Therapy, Dry Heat  
890.5525 Iontophoresis device. II  
  KTB -  Device, Iontophoresis, Specific Uses  
890.5650 Powered inflatable tube massager. II  
  IRP -  Massager, Powered Inflatable Tube  
890.5710 Hot or cold disposable pack. I  
  MPO -  Infant Heel Warmer (Chemical Heat Pack)  
890.5850 Powered muscle stimulator. II  
  NUW -  Stimulator, Muscle, Powered, Dental  
  IPF -  Stimulator, Muscle, Powered  
  NGX -  Stimulator, Muscle, Powered, For Muscle Conditioning  
  NYY -  Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation  
  NYZ -  Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning  
890.5860 Ultrasound and muscle stimulator. II  
  IMG -  Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat  
890.5880 Multi-function physical therapy table. II  
  JFB -  Table, Physical Therapy, Multi Function  
890.5900 Power traction equipment. II  
  ITH -  Equipment, Traction, Powered  

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