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U.S. FDA Medical Device Manual Bed Requirements

FDA Medical Device Definition: A manual adjustable hospital bed is a device intended for medical purposes that consists of a bed with a manual mechanism operated by an attendant to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

Registrar Corp assists Manual Bed companies with:

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