510(k) K251026

Regenesis EMS Chair by Trinity Medical Solutions — Product Code KPI

K251026 is an FDA 510(k) premarket notification submitted by Trinity Medical Solutions for the device "Regenesis EMS Chair". The FDA issued a decision of Substantially Equivalent on August 29, 2025. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320.