FDA.report

510(k) DEN210012

Device
vPatch
Applicant
Virility Medical
510(k) number
DEN210012
Product code
QRC
Decision
Unknown (DENG)
Decision date
2021-11-23
Date received
2021-03-30
Regulation
876.5026
Classification name
Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Direct
Third party reviewed
N

Related Records

Applicant Contact

Contact
Bosmat Friedman
Address
24 Hanagar St., Suite 106 Hod-Hasharon IL 4527713 4527713

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code QRC

510(k)DeviceApplicantDecision date
K252809in2 Smart (in2S)Virility Medical , Ltd.2026-04-06
K241897MORMorari, Inc.2025-02-11
K223595vPATCHVirility Medical , Ltd.2023-05-01