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Notes

§884.1425. Perineometer.

21 C.F.R. § 884.1425

(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).
Notes, amendments, and revision history

Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.