U.S. FDA Medical Device Mechanical Walker Requirements
FDA Medical Device Definition: A mechanical walker is a four-legged device with a metal frame intended for medical purposes to provide moderate weight support while walking. It is used by disabled persons who lack strength, good balance, or endurance.
FDA Mechanical Walker Label Requirements and Exceptions
FDA Mechanical Walker Import Information
FDA Mechanical Walker Detentions (Mechanical Walker Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Mechanical Walker Manufacturers (Mechanical Walker Suppliers)
- Mechanical Walker Distributors
- Mechanical Walker Processors
- Mechanical Walker Repackers
- Mechanical Walker Relabelers
- Mechanical Walker Exporters
- Mechanical Walker Importers
For more information about Mechanical Walker 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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