510(k) K222528

Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode by Well-Life Healthcare Limited — Product Code KPI

K222528 is an FDA 510(k) premarket notification submitted by Well-Life Healthcare Limited for the device "Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode". The FDA issued a decision of Substantially Equivalent on December 29, 2022. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Well-Life Healthcare Limited has at least 10 other 510(k) clearances on record.