21 C.F.R. § 870.5800
Compressible limb sleeve.
Cite as 21 C.F.R. § 870.5800 (2026)
(a) Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. (b) Classification. Class II (performance standards).