KardiaMobile Card
KardiaMobile Card records a single channel electrocardiogram and transfers it to the Kardia smartphone application. The system allows the rhythm recording to be stored, displayed and…
KardiaMobile Card records a single channel electrocardiogram and transfers it to the Kardia smartphone application. The system allows the rhythm recording to be stored, displayed and analyzed in an ambulatory setting. It is intended for healthcare professionals, people with known or suspected heart conditions and health conscious individuals, with pediatric use excluded.
Two dry stainless steel electrodes sense the ECG signal, and the card sends it to a compatible iOS or Android phone through Bluetooth Low Energy. The application presents the recording and synchronizes it with the user’s account. The phone provides the computing platform for these functions.
Listed Item
The AliveCor KardiaMobile Card System is a single-channel electrocardiogram (ECG) device that is intended to record, store, transfer, display, and analyze single-channel ECG rhythms.
Rhythm Analysis
The system displays results from the KardiaAI platform, including classifications for normal sinus rhythm, atrial fibrillation, slow heart rate and fast heart rate. These analyses accompany the single channel rhythm recording.
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (2), Liaoning (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Ryder Electronics (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Shandong Corecare Technology Limited | Jinan | Shandong | Manufacturer | 2 |
Record
| Listed by | AliveCor, United States |
|---|---|
| FDA product code | DXH |
| Device type | Transmitters And Receivers, Electrocardiograph, Telephone |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2920 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K211668 |
| Record published | 2022-07-13 |
| Record revised | 2026-01-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | serial number |
| Storage | Handling environment humidity up to 95 % RH; Handling environment temperature -10 to 40 °C; Storage environment atmospheric pressure 76 to 101 KiloPascal; Storage environment humidity up to 95 % RH; Storage environment temperature 0 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AC-021 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Transmitters And Receivers, Electrocardiograph, Telephone | Proteus Digital Health, Inc. | 10 |
| Sentinel | Spacelabs Healthcare (Washington), Inc | 9 |
| QT ECG | QT Medical, Inc | 7 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 7 |
| LifeWatch Mobile Cardiac Telemetry 3-Lead | Lifewatch Technologies, Ltd. | 6 |
| MAC | GE Medical Systems Information Technologies, Inc. | 5 |
| FibriCheck | Qompium NV | 4 |
| Paceart® System GET Connected III | Medtronic, Inc. | 3 |
| Faros | Bittium Biosignals Ltd. | 3 |
| ECG | Vitalograph Ireland Ltd. | 3 |
| Bioflux | Biotricity | 2 |
| Paceart Optima™ System | Medtronic, Inc. | 2 |
Showing 12 of 66. All products under Transmitters And Receivers, Electrocardiograph, Telephone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220350 | 2022-05-25 |
| K211668 | 2021-11-30 |
| K210753 | 2021-06-30 |
| K191406 | 2020-01-24 |
| K183319 | 2019-05-10 |
| K182396 | 2019-04-12 |
| K171816 | 2017-11-16 |
| K142743 | 2015-01-27 |
| K142672 | 2014-12-03 |
| K140933 | 2014-08-15 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-01-09 | Class III | Software change control | Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application. | 5600 active users with Alive ECG app for iOS. | 2015-02-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.