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U.S. FDA Medical Device Wheelchair Footrest Requirements


FDA Medical Device Definition: A wheelchair component is a device intended for medical purposes that is generally sold as an integral part of a wheelchair, but may also be sold separately as a replacement part. Examples of wheelchair components are the following: Armrest, narrowing attachment, belt, extension brake, curb climber, cushion, antitip device, footrest, handrim, hill holder, leg rest, heel loops, and toe loops.

Registrar Corp assists Wheelchair Footrest companies with:

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