21 CFR 884.5960 — Vibrator For Therapeutic Use, Genital

Obstetrics/Gynecology (OB) · Part 884 Subpart F—Obstetrical and Gynecological Therapeutic Devices · § 884.5960

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).

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KXQVibrator For Therapeutic Use, Genital24
Innolitics

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