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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR888.1500]
See Related Information on Goniometer. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 888 -- ORTHOPEDIC DEVICES

Subpart B--Diagnostic Devices

Sec. 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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