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21 CFR 884.1425

§ 884.1425 Perineometer.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 884.1425, § 884.1425 Perineometer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90784
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(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).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.