The following data is part of a premarket notification filed by Reflexonic, Llc with the FDA for Viberect Penile Vibratory Stimulation Device.
| Device ID | K110566 |
| 510k Number | K110566 |
| Device Name: | VIBERECT PENILE VIBRATORY STIMULATION DEVICE |
| Classification | Vibrator For Therapeutic Use, Genital |
| Applicant | REFLEXONIC, LLC 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Contact | Caroline Tontini |
| Correspondent | Caroline Tontini REFLEXONIC, LLC 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Product Code | KXQ |
| CFR Regulation Number | 884.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-28 |
| Decision Date | 2011-06-24 |
| Summary: | summary |