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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
510(k) Number K252809
Device Name in2 Smart (in2S)
Applicant
Virility Medical , Ltd.
24 Ha-Nagar St.
Hod Hasharon,  IL 4527713
Applicant Contact Natalie Shukrun
Correspondent
Virility Medical , Ltd.
24 Ha-Nagar St.
Hod Hasharon,  IL 4527713
Correspondent Contact Natalie Shukrun
Regulation Number876.5026
Classification Product Code
QRC  
Date Received09/03/2025
Decision Date 04/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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