510(k) K230983

Unicare (K-UNICARE-USA) by Tenscare, Ltd. — Product Code KPI

K230983 is an FDA 510(k) premarket notification submitted by Tenscare, Ltd. for the device "Unicare (K-UNICARE-USA)". The FDA issued a decision of Substantially Equivalent on October 20, 2023. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Tenscare, Ltd. has at least 10 other 510(k) clearances on record.