GroundRules
21 CFR 884.5960: Genital vibrator for therapeutic use.
Where this section sits in the code
- 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
(a) Identification. A genital vibrator for therapeutic use is an electrically operated device intended and labeled for therapeutic use in the treatment of sexual dysfunction or as an adjunct to Kegel's exercise (tightening of the muscles of the pelvic floor to increase muscle tone).
(b) Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in § 884.9.
Collected 2026-08-27T02:24:47Z. Source file · JSON