510(k) K213116

Everyway Incontinence Stimulation System by Everyway Medical Instruments Co.,Ltd — Product Code KPI

K213116 is an FDA 510(k) premarket notification submitted by Everyway Medical Instruments Co.,Ltd for the device "Everyway Incontinence Stimulation System". The FDA issued a decision of Substantially Equivalent on December 3, 2021. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Everyway Medical Instruments Co.,Ltd has at least 10 other 510(k) clearances on record.