21 C.F.R. § 884.1425

Perineometer.

Last amended: 2016Year: 2026Length: 63 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 884.1425 (2026)

(a) Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction. (b) Classification. Class II (performance standards).
21 C.F.R. § 884.1425: Perineometer. | Justis AI