510(k) Report

Devices descending from K201525

3 later devices reach ECG App through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240795Withings ECG AppWithings20250—
+1K243236WHOOP ECG (electrocardiogram) Feature (1.0)Whoop., Inc.20250—
+1K240909Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.20240—