VIBERECT PENILE VIBRATORY STIMULATION DEVICE
FDA 510(k) clearance K110566 · decided 2011-06-24
Clearance details
- K-number
- K110566
- Device name
- VIBERECT PENILE VIBRATORY STIMULATION DEVICE
- Applicant
- Reflexonic, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-02-28
- Decision date
- 2011-06-24
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- KXQ
- Device class
- 2
- Regulation number
- 884.5960
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Reflexonic
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 (K142304) | Reflexonic, LLC | 2014-10-03 |
| 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.