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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Ave., Suite 205
Frederick,  MD  21701
Applicant Contact Kambiz Tajkarimi
Correspondent
Emergo Group
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact Julie Powell
Regulation Number884.5960
Classification Product Code
KXQ  
Date Received08/18/2014
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
Predetermined Change
Control Plan Authorized		 No
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