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U.S. FDA Medical Device Patient Scale Requirements

FDA Medical Device Definition: A patient scale is a device intended for medical purposes that is used to measure the weight of a patient who cannot stand on a scale. This generic device includes devices placed under a bed or chair to weigh both the support and the patient, devices where the patient is lifted by a sling from a bed to be weighed, and devices where the patient is placed on the scale platform to be weighed. The device may be mechanical, battery powered, or AC-powered and may include transducers, electronic signal amplification, conditioning and display equipment.

Registrar Corp assists Patient Scale companies with:

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