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U.S. FDA Medical Device Pinwheel Requirements

FDA Medical Device Definition: A pinwheel is a device with sharp points on a rotating wheel used for testing pain sensation.

Registrar Corp assists Pinwheel companies with:

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