§878.5910. Pneumatic tourniquet.
21 C.F.R. § 878.5910
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.
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.
Notes, amendments, and revision history
Amendments
[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 53 FR 23872, June 24, 1988, unless otherwise noted.
Amendments
[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001]