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U.S. FDA Medical Device Therapeutic Bed Requirements

FDA Medical Device Definition: An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

Registrar Corp assists Therapeutic Bed companies with:

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