U.S. FDA Medical Device Wheelchair Footrest 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.
FDA Wheelchair Footrest Establishment Registration
FDA Wheelchair Footrest Listing
FDA Wheelchair Footrest Label Requirements and Exceptions
FDA Wheelchair Footrest Import Information
FDA Wheelchair Footrest Detentions (Wheelchair Footrest Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Wheelchair Footrest Manufacturers (Wheelchair Footrest Suppliers)
- Wheelchair Footrest Distributors
- Wheelchair Footrest Processors
- Wheelchair Footrest Repackers
- Wheelchair Footrest Relabelers
- Wheelchair Footrest Exporters
- Wheelchair Footrest Importers
For more information about Wheelchair Footrest Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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