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U.S. FDA Medical Device Immersion Hydrobath Requirements: Immersion Hydrobath

FDA Medical Device Definition: An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue

Registrar Corp assists Immersion Hydrobath companies with:

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

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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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