510(k) · Cardiovascular

AI-ECG Tracker

by Shenzhen Carewell Electronics Co., Ltd.

AI-ECG Tracker is an AI-enabled medical device from Shenzhen Carewell Electronics Co., Ltd. that the U.S. FDA cleared through 510(k) K200036 on March 20, 2020. Its lead review panel is Cardiovascular and its primary product code is DPS (Electrocardiograph).

See also FDA-cleared AI cardiovascular devices in 2020, all FDA AI clearances in 2020, top cardiovascular AI devices.

Key facts

Submission numberK200036
Pathway510(k)
Date of final decision
Company (FDA list)Shenzhen Carewell Electronics Co., Ltd.
Lead review panelCardiovascular
Primary product codeDPS — Electrocardiograph
Applicant (openFDA)Shenzhen Carewell Electronics Co., Ltd.
Applicant locationShenzhen, CN
Device classClass 2
Regulation number21 CFR 870.2340
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. AI-ECG Tracker went through this pathway (K200036).

openFDA lists it as a Class 2 device under 21 CFR 870.2340. Class II devices are moderate risk and are subject to general and special controls.

Product code DPS covers 7 devices on the FDA AI list. By decision date, this device is #4 of 7 under that code. Shenzhen Carewell Electronics Co., Ltd. has 1 AI-enabled device on the list, and the Cardiovascular panel accounts for 154 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

Similar devices (product code DPS)