Device Classification Name |
vibrator for therapeutic use, genital
|
510(k) Number |
K142304 |
Device Name |
Viberect Penile Vibratory Stimulation Device |
Applicant |
REFLEXONIC, LLC |
915 Toll House Avenue, Suite 205 |
Frederick,
MD
21701
|
|
Applicant Contact |
Kambiz Tajkarimi |
Correspondent |
EMERGO GROUP |
816 CONGRESS AVENUE |
SUITE 1400 |
AUSTIN,
TX
78701
|
|
Correspondent Contact |
Julie Powell |
Regulation Number | 884.5960
|
Classification Product Code |
|
Date Received | 08/18/2014 |
Decision Date | 10/03/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|