21 CFR § 884.5960 - Genital vibrator for therapeutic use.

---
identifier: "/us/cfr/t21/s884.5960"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 884.5960 - Genital vibrator for therapeutic use."
title_number: 21
title_name: "Food and Drugs"
section_number: "884.5960"
section_name: "Genital vibrator for therapeutic use."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "884"
part_name: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "45 FR 12684, Feb. 26, 1980, unless otherwise noted."
cfr_part: "884"
---


# 884.5960 Genital vibrator for therapeutic use.

(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.

[45 FR 12684, Feb. 26, 1980, as amended at 83 FR 29215, June 5, 2018]