VIBERECT PENILE VIBRATORY STIMULATION DEVICE


Device Classification Name

vibrator for therapeutic use, genital

510(k) Number K110566
Device Name VIBERECT PENILE VIBRATORY STIMULATION DEVICE
Applicant
REFLEXONIC, LLC
611 west 5th street
third floor
austin, 
TX 
78701

Applicant Contact caroline tontini
Correspondent
REFLEXONIC, LLC
611 west 5th street
third floor
austin, 
TX 
78701

Correspodent Contact caroline tontini
Regulation Number 884.5960
Classification Product Code
KXQ  
Date Received 02/28/2011
Decision Date 06/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No