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

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