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

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