{"data":{"id":"us/21-cfr-884.5970","jurisdiction":"us","citation":"21 CFR 884.5970","heading":"Clitoral engorgement device.","body":"(a) Identification. A clitoral engorgement device is designed to apply a vacuum to the clitoris. It is intended for use in the treatment of female sexual arousal disorder.\n(b) Classification. Class II (special controls). The special control is a guidance document entitled: “Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for Clitoral Engorgement Devices.”","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 F—Obstetrical and Gynecological Therapeutic 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":"92e9df6172f3ca9f0ddd51c04dadd8ecf2808cc402b5faad1c1e0771feba9a28","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-884.5960","next":"us/21-cfr-884.5980"},"notice":"GroundRules: Original legal text. Not legal advice."}