The following data is part of a premarket notification filed by Reflexonic, Llc with the FDA for Viberect Penile Vibratory Stimulation Device.
| Device ID | K142304 |
| 510k Number | K142304 |
| Device Name: | Viberect Penile Vibratory Stimulation Device |
| Classification | Vibrator For Therapeutic Use, Genital |
| Applicant | REFLEXONIC, LLC 915 Toll House Avenue, Suite 205 Frederick, MD 21701 |
| Contact | Kambiz Tajkarimi |
| Correspondent | Julie Powell EMERGO GROUP 816 CONGRESS AVENUE SUITE 1400 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 | 2014-08-18 |
| Decision Date | 2014-10-03 |
| Summary: | summary |