Viberect Penile Vibratory Stimulation Device
FDA 510(k) clearance K142304 · decided 2014-10-03
Clearance details
- K-number
- K142304
- Device name
- Viberect Penile Vibratory Stimulation Device
- Applicant
- Reflexonic, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-08-18
- Decision date
- 2014-10-03
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- KXQ
- Device class
- 2
- Regulation number
- 884.5960
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Frederick, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VIBERECT PENILE VIBRATORY STIMULATION DEVICE (K110566) | Reflexonic, LLC | 2011-06-24 |
| MULTI CARE THERAPEUTIC VIBRATOR (K010096) | Multicept A/S | 2001-03-05 |
| FERTICARE PERSONAL THERAPEUTIC VIBRATOR (K955589) | Multicept, Aps. | 1996-04-11 |
Recalls involving this device
No recalls on record reference this clearance.