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.
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.
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