ClearanceBrief
510(k) K251026 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence

Regenesis EMS Chair

ApplicantTrinity Medical Solutions, Birmingham AL, US
DecisionSubstantially Equivalent, Aug 29, 2025
ReceivedApr 2, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251026

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.