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U.S. FDA Medical Device Mechanical Treadmill Requirements

FDA Medical Device Definition: Nonmeasuring exercise equipment consist of 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 prone scooter board, parallel bars, a mechanical treadmill, an exercise table, and a manually propelled exercise bicycle.

Registrar Corp assists Mechanical Treadmill companies with:

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