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U.S. FDA Medical Device Ice Bag Requirements

FDA Medical Device Definition: An ice bag is a device intended for medical purposes that is in the form of a container intended to be filled with ice that is used to apply dry cold therapy to an area of the body. The device may include a holder that keeps the bag in place against an external area of the patient.

Registrar Corp assists Ice Bag companies with:

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