510(k) K241516

BTL-398 by BTL Industries, Inc. — Product Code KPI

K241516 is an FDA 510(k) premarket notification submitted by BTL Industries, Inc. for the device "BTL-398". The FDA issued a decision of Substantially Equivalent on February 10, 2025. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. BTL Industries, Inc. has at least 10 other 510(k) clearances on record.