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

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