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U.S. FDA Medical Device Wheelchair Lap Board Requirements

FDA Medical Device Definition: A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.

Registrar Corp assists Wheelchair Lap Board companies with:

  • FDA Wheelchair Lap Board Establishment Registration
  • FDA Wheelchair Lap Board Listing
  • FDA Wheelchair Lap Board Label Requirements and Exceptions
  • FDA Wheelchair Lap Board Import Information
  • FDA Wheelchair Lap Board Detentions (Wheelchair Lap Board Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Wheelchair Lap Board Manufacturers (Wheelchair Lap Board Suppliers)
       - Wheelchair Lap Board Distributors
       - Wheelchair Lap Board Processors
       - Wheelchair Lap Board Repackers
       - Wheelchair Lap Board Relabelers
       - Wheelchair Lap Board Exporters
       - Wheelchair Lap Board Importers
For more information about Wheelchair Lap Board Medical Devices, simply click below:

U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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