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e-CFR data is current as of September 21, 2020

Title 21Chapter ISubchapter HPart 888Subpart B → §888.1500


Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart B—Diagnostic Devices


§888.1500   Goniometer.

(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.

[65 FR 19319, Apr. 11, 2000]

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