Kardia Mobile
KardiaMobile is a personal EKG device that is capable of recording a Single-Lead EKG. It has two electrodes on the top surface and is powered by a replaceable battery located on the back of…
KardiaMobile is a personal EKG device that is capable of recording a Single-Lead EKG. It has two electrodes on the top surface and is powered by a replaceable battery located on the back of the device. Ultrasonic transmission is used to wirelessly transmit EKG data from the device to your smartphone or tablet.
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 |
| Record published | 2016-09-24 |
| Record revised | 2026-01-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AC-009 | 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.