21 C.F.R. § 884.1425

Current through May 31, 2024
Section 884.1425 - Perineometer
(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