Identity
- Device Name
- AI-ECG Tracker EUDAMED
- Model / Reference
- S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971049341987 EUDAMED
- Basic UDI-DI
- B-06971049341987 EUDAMED
- 510(k) Number
- K200036 FDA 510(k)
- FDA Product Code
- DPS FDA 510(k)
- EMDN Code
- Z12050392 ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2340 FDA 510(k)
- Regulation Number
- 870.2340 FDA 510(k)
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The AI-ECG Tracker is an electrocardiograph (product code DPS) designed for the analysis of ECG data. It employs artificial intelligence to monitor and assess cardiac electrical activity, supporting the detection and evaluation of arrhythmias through automated interpretation of heart rhythm patterns.
This device is intended for use in clinical settings, supplied as a reusable medical instrument. It is classified under FDA 510(k) clearance (K200036) and adheres to the Medical Device Directive (MDD). The AI-ECG Tracker is regulated under Class II – Special Controls for cardiovascular applications, with no third-party involvement in its review process.
Frequently asked questions
What clinical applications is the AI-ECG Tracker primarily designed to support in a hospital setting?
The AI-ECG Tracker is specifically designed for monitoring and analyzing electrocardiogram (ECG) data to detect and evaluate arrhythmias. By using artificial intelligence, it automates the interpretation of heart rhythm patterns, making it useful for identifying irregularities in cardiac electrical activity during patient care.
Is the AI-ECG Tracker a single-use or reusable device, and how does this affect its maintenance?
The AI-ECG Tracker is supplied as a reusable medical instrument, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance. Since it is reusable, facilities must follow established protocols for reprocessing to ensure safety, functionality, and compliance with regulatory standards.
What regulatory pathways does the AI-ECG Tracker follow, and how does this impact its use in clinical environments?
The AI-ECG Tracker has received FDA 510(k) clearance (K200036) under the Traditional pathway, demonstrating substantial equivalence to a predicate device. It also complies with the Medical Device Directive (MDD). These approvals confirm its safety and effectiveness for cardiovascular applications, ensuring it meets stringent regulatory requirements before use in clinical settings.
How is the AI-ECG Tracker classified under FDA regulations, and what does this classification imply for its oversight?
The AI-ECG Tracker falls under FDA Class II – Special Controls for cardiovascular applications, which means it is subject to additional scrutiny beyond general controls. This classification ensures rigorous evaluation of its performance, labeling, and manufacturing processes to maintain patient safety, particularly in monitoring heart rhythm disorders.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Shenzhen Carewell Electronics: Products, FDA Status & Funding ..., K200036 - AI-ECG Tracker | FDA 510 (k), AI-ECG Tracker (K200036) — FDA 510 (k) | Innolitics, PDF AI-ECG Tracker Operator's Manual - carewell.com.cn
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K200036 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Carewell Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K200036 24 fields · synced Sep 18, 2026
- EUDAMED e1ffc09b-8270-4322-bec9-e7f49f5fb088 61 fields · synced Jul 23, 2026