510(k) K252389

Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) by Smwmed, Inc. — Product Code DSH

K252389 is an FDA 510(k) premarket notification submitted by Smwmed, Inc. for the device "Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)". The FDA issued a decision of Substantially Equivalent on April 23, 2026. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800.