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e-CFR data is current as of July 9, 2020

Title 21Chapter ISubchapter HPart 884Subpart F → §884.5960


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.

(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]

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