Vibrator For Therapeutic Use, Genital
The Genital Vibrator for Therapeutic Use is a device intended for therapeutic applications in the treatment of sexual dysfunction or pelvic floor conditions in a clinical or personal health context. It is classified as FDA Class 2, indicating moderate risk, subject to general controls and special controls, and does not require a premarket submission under the submission type assigned. The product code is KXQ, regulated under 21 CFR 884.5960, in the Obstetrics/Gynecology medical specialty. No special flags apply to this device.
Basic Information
- Product Code
- KXQ
- Device Class
- FDA class 2
- Regulation Number
- 884.5960
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K142304 | Viberect Penile Vibratory Stimulation Device | Oct 03, 2014 | Substantially Equivalent | Reflexonic, LLC |
| K110566 | VIBERECT PENILE VIBRATORY STIMULATION DEVICE | Jun 24, 2011 | Substantially Equivalent | Reflexonic, LLC |
| K010096 | MULTI CARE THERAPEUTIC VIBRATOR | Mar 05, 2001 | Substantially Equivalent | Multicept A/S |
| K955589 | FERTICARE PERSONAL THERAPEUTIC VIBRATOR | Apr 11, 1996 | Substantially Equivalent | Multicept, Aps. |
FEI Numbers
This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.