21 CFR 884.5960 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — Obstetrical And Gynecological Devices (§ 884.1 To § 884.6200) — Obstetrical And Gynecological Therapeutic Devices (§ 884.5050 To § 884.5980) — Genital vibrator for therapeutic use.

4 Aug 2016

(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).

21 CFR 884.5960