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U.S. FDA Medical Device AC-Powered Goniometer Requirements


FDA Medical Device Definition: A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint.AC-Powered_Keratoscope=A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.

Registrar Corp assists AC-Powered Goniometer companies with:

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