21 CFR § 878.5900 General and Plastic Surgery Devices

§ 878.5900 Nonpneumatic tourniquet.

Current through Sep 8, 2026 · Read all of Part 878

(a) Identification. A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's limb and tightened to reduce circulation.

(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.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]

← § 878.5650 Topical oxygen chamber for extremities.§ 878.5910 Pneumatic tourniquet. →