{"data":{"id":"us/21-cfr-884.1425","jurisdiction":"us","citation":"21 CFR 884.1425","heading":"Perineometer.","body":"(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.\n(b) Classification. Class II (performance standards).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES","Subpart B—Obstetrical and Gynecological Diagnostic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"985c0dbd50362d577ef8d38844674e9ed83eedcc7896b797cbae03202257e14f","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-884.1300","next":"us/21-cfr-884.1550"},"notice":"GroundRules: Original legal text. Not legal advice."}