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