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U.S. FDA Medical Device Pelvic Belt 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 Pelvic Belt companies with:

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