FERTICARE PERSONAL THERAPEUTIC VIBRATOR
Device Facts
| Record ID | K955589 |
|---|---|
| Device Name | FERTICARE PERSONAL THERAPEUTIC VIBRATOR |
| Applicant | Multicept, Aps. |
| Product Code | KXQ · Obstetrics/Gynecology |
| Decision Date | Apr 11, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5960 |
| Device Class | Class 2 |
Regulatory Classification
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).
