U.S. FDA Medical Device Powered Exerciser Requirements
FDA Medical Device Definition: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a powered treadmill, a powered bicycle, and powered parallel bars.
FDA Powered Exerciser Label Requirements and Exceptions
FDA Powered Exerciser Import Information
FDA Powered Exerciser Detentions (Powered Exerciser Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Powered Exerciser Manufacturers (Powered Exerciser Suppliers)
- Powered Exerciser Distributors
- Powered Exerciser Processors
- Powered Exerciser Repackers
- Powered Exerciser Relabelers
- Powered Exerciser Exporters
- Powered Exerciser Importers
For more information about Powered Exerciser 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.