21 CFR § 884.1425 Obstetrical and Gynecological Devices

§ 884.1425 Perineometer.

Current through Sep 8, 2026 · Read all of Part 884

(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).

← § 884.1300 Uterotubal carbon dioxide insufflator and accessories.§ 884.1550 Amniotic fluid sampler (amniocentesis tray). →