Cardiovascular · 510(k) · 2020
AI-ECG Tracker
Shenzhen Carewell Electronics Co., Ltd.. Cleared by FDA on 20 March 2020 under submission K200036, product code DPS (electrocardiograph). What FDA's record says, in FDA's words.
Device record · K200036
- Device. AI-ECG TrackerDEVICE
- Company. Shenzhen Carewell Electronics Co., Ltd. (CN)COMPANY
- Decision. 20 March 2020, 510(k), substantially equivalent (traditional review); received 8 January 2020DECISION
- Panel. CardiovascularPANEL
- Product code. DPS, ElectrocardiographCODE
- Regulation. 21 CFR 870.2340, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The AI-ECG Tracker is intended to be used by qualified healthcare professionals in hospitals and healthcare facilities for the assessment of arrhythmias using ECG data acquired from adults (age 22 and older) without pacemakers. The product supports downloading and analyzing data recorded from electrodes with conductive paste/gel placed on standard location in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12-lead ambulatory ECG devices when assessment of the rhythm is necessary. The AI-ECG Tracker provides ECG signal processing and analysis on a beat by beat basis, QRS detection, Supraventricular and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. The AI-ECG Tracker is not for use in life supporting or sustaining systems or ECG monitoring and Alarm devices. The AI-ECG Tracker interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 898 reports filed against devices carrying product code DPS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
25 September 2026 · Malfunction · DECGPageWriter TC S · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-102027
25 September 2026 · Malfunction · PageWriter · Philips Medical Systems · report 1218950-2026-100667
18 September 2026 · Malfunction · Q-Stress · BAXTER HEALTHCARE CORPORATION · report 3006087789-2026-00025
Baxter received a report stating that an exam was done earlier under the wrong patient information. This occurred after patient use. There was no patient injury or death reported with this event.
16 September 2026 · Malfunction · Midmark Digital ECG Plug-In Software Version 10.2.2 · Midmark Corporation · report 1523530-2026-00012
It was reported by 15 customers that they were getting a high heart rate on the ECG. The ECG did not calculate the heart rate correctly due to multiple instances of the ECG Plug-in being opened concurrently. The doctor reviewed the results and no medication was given or harm occurred. The customers were sent the firmware update as they were on the old firmware Plug-in version.
16 September 2026 · Malfunction · Cardiac Workstation · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-101917
It was reported that the heart rate reading is inaccurate. It is unknown if the device was in use on a patient. There was no report of patient or user harm.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code DPS, in Cardiovascular, or cleared in 2020. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.