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U.S. FDA Medical Device Abdominal Binder Requirements

FDA Medical Device Definition: A therapeutic medical binder is a device, usually made of cloth, that is intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place. This generic type of device includes the abdominal binder, breast binder, and perineal binder.

Registrar Corp assists Abdominal Binder companies with:

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