21 C.F.R. § 884.5960 Genital vibrator for therapeutic use.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart F—Obstetrical and Gynecological Therapeutic Devices
§ 884.5960 Genital vibrator for therapeutic use.
