21 CFR 878.5910
§ 878.5910 Pneumatic tourniquet.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 878.5910, § 878.5910 Pneumatic tourniquet, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90491
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Full text
(a) Identification. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.