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U.S. FDA Medical Device Flotation Therapy Bed Requirements


FDA Medical Device Definition: A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.

Registrar Corp assists Flotation Therapy Bed companies with:

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