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U.S. FDA Medical Device Wheelchair Anti-Tip Device 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 Anti-Tip Device companies with:

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