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