21 CFR 884.5960
§ 884.5960 Genital vibrator for therapeutic use.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 884.5960, § 884.5960 Genital vibrator for therapeutic use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90867
- Permanent ID
ys:prov:90867@1- SHA-256
c974b00a8e4336220d5d1d374fcad086227b8ddeb29cb05c5e8a151b0e3c22cd
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.