21 C.F.R. § 870.1120
Blood pressure cuff.
Cite as 21 C.F.R. § 870.1120 (2026)
(a)
Identification.
A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.
(b)
Classification.
Class II (performance standards).