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Code of Federal Regulations Title 21. Food and Drugs § 21.888.1500 Goniometer

Current as of January 02, 2025 | Updated by Findlaw Staff

(a) Identification. 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.

(b) Classification.

(1) Class I (general controls) for a goniometer that does not use electrode lead wires and patient cables. This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.

(2) Class II (special controls) for a goniometer that uses electrode lead wires and patient cables. The special controls consist of:

(i) The performance standard under part 898 of this chapter, and

(ii) The guidance entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.888.1500 Goniometer - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-888-1500/

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