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U.S. FDA Medical Device Traction Head Halter Requirements

FDA Medical Device Definition: A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient's body.

Registrar Corp assists Traction Head Halter companies with:

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