510(k) Report

Devices descending from K231289

3 later devices reach S-Patch Ex Wearable ECG Patch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7…Seers Technology Co., Ltd.20260—
+1K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.20260—
+1K233906S-Patch (S-Patch ExL)Wellysis Corp.20240—