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

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