Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)

Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) is an FDA 510(k)-cleared medical device (K252389) manufactured by Smwmed, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 22, 2026. Regulation: 8.