510(k) K252839

ZywieZ3 Sensor & Adhesive by Zywie, Inc. — Product Code MWJ

K252839 is an FDA 510(k) premarket notification submitted by Zywie, Inc. for the device "ZywieZ3 Sensor & Adhesive". The FDA issued a decision of Substantially Equivalent on June 18, 2026. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. Zywie, Inc. has at least 1 other 510(k) clearance on record.