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U.S. FDA Medical Device Sitz Bat Requirements

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 Sitz Bat companies with:

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