21 C.F.R. § 888.1240

Current through October 31, 2024
Section 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 .

21 C.F.R. §888.1240

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