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U.S. FDA Medical Device Wheelchair Cushion 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 Cushion companies with:

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