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Code · CFR · Title 21 — Food and Drugs · Part 888 — Orthopedic Devices · § 888.1240

§ 888.1240. AC-powered dynamometer.

88 words·~1 min read·/us/cfr/t21/s§ 888.1240·

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(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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