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

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