Who else makes this device?

Name: KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L Max
Brand: KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L Max

Cardiovascular › MonitoringTransmitters And Receivers, Electrocardiograph, Telephone

KardiaMobile 6l System, KardiaMobile 6l Max, Kardia 6l Max

KardiaMobile 6L System is a 3-electrode personal EKG device that is capable of recording two kinds of EKGs: a Single-Lead EKG and a Six-Lead EKG, which provides more data for you to share…

Registry build 21.09.26

KardiaMobile 6L System is a 3-electrode personal EKG device that is capable of recording two kinds of EKGs: a Single-Lead EKG and a Six-Lead EKG, which provides more data for you to share with your doctor. Both EKG types detect normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and indeterminate results (errors or unclassified rhythms). The KardiaMobile 6L System hardware has two electrodes on the top surface and one on the bottom surface. It is powered by a replaceable battery, which is located under the bottom electrode. Bluetooth is used to wirelessly transmit EKG data from the device to your smartphone or tablet.

6manufacturers in China registered for this device type

1catalogue number

10510(k) clearances naming this product code

1recall

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.

Chinese manufacturers registered for FDA product code DXH
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

Regulatory record for KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L Max
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	2020-05-01
Record revised	2026-07-15 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Over the counter	Yes
Label carries	serial number

Catalogue Numbers

Catalogue numbers for KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L Max
Catalogue number	Size	Status
AC-019		In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Recalls referencing this product code
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.