Title 21

SECTION 888.1240

888.1240 AC-powered dynamometer.

§ 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]