KXQ · Vibrator For Therapeutic Use, Genital
Obstetrics/Gynecology · 21 CFR 884.5960 · Class 2
Overview
| Product Code | KXQ |
|---|---|
| Device Name | Vibrator For Therapeutic Use, Genital |
| Regulation | 21 CFR 884.5960 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K142304 | Viberect Penile Vibratory Stimulation Device | Reflexonic, LLC | Oct 3, 2014 | SESE |
| K110566 | VIBERECT PENILE VIBRATORY STIMULATION DEVICE | Reflexonic, LLC | Jun 24, 2011 | SESE |
| K010096 | MULTI CARE THERAPEUTIC VIBRATOR | Multicept A/S | Mar 5, 2001 | SESE |
| K955589 | FERTICARE PERSONAL THERAPEUTIC VIBRATOR | Multicept, Aps. | Apr 11, 1996 | SESE |
Top Applicants
- Reflexonic, LLC — 2 clearances
- Multicept A/S — 1 clearance
- Multicept, Aps. — 1 clearance
