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U.S. FDA Medical Device Pneumatic Tourniquet Requirements

FDA Medical Device Definition: A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.

Registrar Corp assists Pneumatic Tourniquet companies with:

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