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U.S. FDA Medical Device Wheelchair Extension Brake 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 Extension Brake companies with:

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