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U.S. FDA Medical Device Traction Accessories Requirements

FDA Medical Device Definition: A traction accessory is a nonpowered accessory device intended for medical purposes to be used with powered traction equipment to aid in exerting therapeutic pulling forces on the patient's body. This generic type of device includes the pulley, strap, head halter, and pelvic belt.

Registrar Corp assists Traction Accessories companies with:

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