510(k) K171430

Incontinence Treatment Device, Model LT2061 by Shenzhen Dongdixin Technology Co., Ltd. — Product Code KPI

K171430 is an FDA 510(k) premarket notification submitted by Shenzhen Dongdixin Technology Co., Ltd. for the device "Incontinence Treatment Device, Model LT2061". The FDA issued a decision of Substantially Equivalent on March 15, 2018. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Shenzhen Dongdixin Technology Co., Ltd. has at least 10 other 510(k) clearances on record.