ClearanceBrief
510(k) K252809 ยท QRC Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

in2 Smart (in2S)

ApplicantVirility Medical , Ltd., Hod Hasharon, IL
DecisionSubstantially Equivalent, Apr 6, 2026
ReceivedSep 3, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K252809

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.