Product code

AI devices with FDA product code DPS — Electrocardiograph

Product code DPS (“Electrocardiograph” in openFDA) covers 7 devices on the FDA AI-enabled list, from 7 companies. Most are reviewed by the Cardiovascular panel (7). The most recent decision was Cardiologs Holter Platform on August 6, 2025.

7AI devices

7Companies

2017First decision

2025-08-06Latest decision

Trend: devices per year

2017201820192020202320242025

AI devices with FDA product code DPS — Electrocardiograph per year: 2017 1, 2018 1, 2019 1, 2020 1, 2023 1, 2024 1, 2025 1

Top companies

Philips France Commercial1
AliveCor, Inc.1
Withings1
Shenzhen Carewell Electronics Co., Ltd.1
physIQ, Inc1
Cardio-Phoenix Inc.1
Cardiologs Technologies1

All 7 devices, newest first

Cardiologs Holter PlatformPhilips France Commercial · CardiovascularK2505692025-08-06
ImpalaAliveCor, Inc. · CardiovascularK2320352024-06-07
Withings Scan Monitor 2.0Withings · CardiovascularK2308122023-08-23
AI-ECG TrackerShenzhen Carewell Electronics Co., Ltd. · CardiovascularK2000362020-03-20
physIQ Heart Rhythm and Respiratory ModulephysIQ, Inc · CardiovascularK1833222019-07-10
Cardio-TriTest v6.5Cardio-Phoenix Inc. · CardiovascularK1827902018-12-14
CardioLogs ECG Analysis PlatformCardiologs Technologies · CardiovascularK1705682017-06-26