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U.S. FDA Medical Device Flotation Cushion Requirements

FDA Medical Device Definition: A flotation cushion is a device intended for medical purposes that is made of plastic, rubber, or other type of covering, that is filled with water, air, gel, mud, or any other substance allowing a flotation media, used on a seat to lessen the likelihood of skin ulcers.

Registrar Corp assists Flotation Cushion companies with:

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