21 C.F.R. § 870.5925
Automatic rotating tourniquet.
Cite as 21 C.F.R. § 870.5925 (2026)
(a)
Identification.
An automatic rotating tourniquet is a device that prevents blood flow in one limb at a time, which temporarily reduces the total blood volume, thereby reducing the normal workload of the heart.
(b)
Classification.
Class II (performance standards).