C.F.R. » Title 21 » 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

21 C.F.R. § 884.5960

Genital vibrator for therapeutic use

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(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]
Notes of Decisions
Cited in 2 cases, 1981–2002 · leading case: Postscript Enter., Inc. v. Whaley, 658 F.2d 1249 (8th Cir. 1981).
Sort: Relevance Newest Treatment
Postscript Enter., Inc. v. Whaley, 658 F.2d 1249 (8th Cir. 1981). “Assuming that genital vibrators might be sex-inciting devices or contrivances, a problem arises because these items also have non-sex-inciting purposes which have been set forth in FDA regulations at 21 C.F.R. § 884.5960 (a) (1980): “A genital vibrator for therapeutic use is an…”
Pleasureland Museum v. Beutter, Robert C., 288 F.3d 988 (7th Cir. 2002). · cites it 2× “, 1993) (“Handboox”) (listing vibratory use as necessary step to treat certain cases of female anorgasmia). In addition, FDA regulations conclusively establish the therapeutic and medical value of certain sexual devices.”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.