510(k) Report

Devices descending from K171410

7 later devices reach ePatch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.20260—
+1K231289S-Patch Ex Wearable ECG PatchWellysis Corp.20233—
+1K211709BiotresBiotricity20222—
+2K253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7…Seers Technology Co., Ltd.20260—
+2K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.20240—
+2K233906S-Patch (S-Patch ExL)Wellysis Corp.20240—
+2K222017BiotresBiotricity20220—