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U.S. FDA Medical Device Elastic 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 Elastic Binder companies with:

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