510(k) Report

Devices descending from K090363

17 later devices reach Zio Patch, Model Z100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113176Mysense HeartCardiac Science Corporation201116—
+2K131190MypatchDms-Service, LLC201315—
+3K171410ePatchBraemar Manufacturing, LLC20187—
+3K160704myPatch-sDms-Service, LLC201614—
+4K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.20260—
+4K231289S-Patch Ex Wearable ECG PatchWellysis Corp.20233—
+4K211709BiotresBiotricity20222—
+4K163535my Patch slDms-Service, LLC20175—
+5K253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7…Seers Technology Co., Ltd.20260—
+5K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.20240—
+5K233906S-Patch (S-Patch ExL)Wellysis Corp.20240—
+5K222017BiotresBiotricity20220—
+5K210758Q PatchMedicalgorithmics S.A.20221—
+5K203168LifeLens Wireless ECG MonitorLifeLens Technologies, Inc.20211—
+5K202456M5 RecorderGlobal Instrumentation, LLC20200—
+6K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+6K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.20260—