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21 CFR 888.1240

§ 888.1240 AC-powered dynamometer.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 888.1240, § 888.1240 AC-powered dynamometer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91046
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Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.