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U.S. FDA Medical Device Wheeled Stretcher Requirements

FDA Medical Device Definition: A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps. The frame may be fixed or collapsible for use in an ambulance.

Registrar Corp assists Wheeled Stretcher companies with:

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