510(k) Report

Devices descending from K131699

16 later devices reach Emotion Ecg Mobile through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143032eMotion Faros ECG MobileMega Electronics, Ltd.20156—
+1K141813Rhythmstar SystemRhythMedix, LLC20148—
+2K233584RhythmStar SystemRhythMedix, LLC20241—
+2K183704RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20192—
+2K172311BioFlux DeviceBiotricity, Inc.20171—
+2K172801ECG SENTINEL SystemCardiomedix, Inc.20170—
+2K161431SimplECGNanowear, Inc.20165—
+3K250793RhythmStar System (SL)RhythMedix, LLC20260—
+3K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.20240—
+3K201669SimpleSENSENanowear, Inc.20203—
+3K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20201—
+3K173248CardioskinBioserenity Sas20180—
+4K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+4K241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.20250—
+4K212160SimpleSENSE PlatformNanowear, Inc.20211—
+5K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—