§888.1240. AC-powered dynamometer.
21 C.F.R. § 888.1240
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.
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.
Notes, amendments, and revision history
Amendments
[52 FR 33702, Sept. 4, 1987, as amended at 84 FR 71818, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.
Amendments
[52 FR 33702, Sept. 4, 1987, as amended at 84 FR 71818, Dec. 30, 2019]