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e-CFR data is current as of May 10, 2021

Title 21Chapter ISubchapter HPart 888 → Subpart B


Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES


Subpart B—Diagnostic Devices


Contents
§888.1100   Arthroscope.
§888.1240   AC-powered dynamometer.
§888.1250   Nonpowered dynamometer.
§888.1500   Goniometer.
§888.1520   Nonpowered goniometer.

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§888.1100   Arthroscope.

(a) Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

(b) Classification. (1) Class II (performance standards).

(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38815, July 25, 2001]

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§888.1240   AC-powered dynamometer.

(a) Identification. An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §886.9.

[52 FR 33702, Sept. 4, 1987, as amended at 84 FR 71818, Dec. 30, 2019]

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§888.1250   Nonpowered dynamometer.

(a) Identification. A nonpowered dynamometer is a mechanical device intended for medical purposes to measure the pinch and grip muscle strength of a patient's hand.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807.

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§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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§888.1520   Nonpowered goniometer.

(a) Identification. A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]

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