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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name non-implanted electrical stimulation device for management of premature ejaculation
De Novo Number DEN210012
Device Name vPatch
Virility Medical
24 hanagar st., suite 106
hod-hasharon,  IL 4527713
Contact bosmat friedman
Regulation Number876.5026
Classification Product Code
Date Received03/30/2021
Decision Date 11/23/2021
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
Type Direct