Who else makes this device?

Name: Smartheart
Brand: Smartheart

Cardiovascular › MonitoringTransmitters And Receivers, Electrocardiograph, Telephone

Smartheart

The SmartHeart is a portable battery powered, 12-lead ECG and rhythm strip device with Bluetooth connection. SmartHeart acquires ECG data via electrodes on the housing and the electrode…

Registry build 21.09.26

The SmartHeart is a portable battery powered, 12-lead ECG and rhythm strip device with Bluetooth connection. SmartHeart acquires ECG data via electrodes on the housing and the electrode belt placed on the chest and electrodes in the left and right armpits and the waist. SmartHeart transmits the data in real-time to a suitable Bluetooth communication device (smartphone or tablet) equipped with a Mobile Application so that it can be forwarded to the remote location equipped by Cardio Medical Center Vision (K003392) or equivalent software for a medical professional review.

6manufacturers in China registered for this device type

2catalogue numbers in this listing

3510(k) clearances naming this product code

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 Smartheart
Listed by	SHL TeleMedicine International, Israel
FDA product code	DXH
Device type	Transmitters And Receivers, Electrocardiograph, Telephone
Device class	Class 2
Regulation	21 CFR 870.2920
Establishment	Manufacturer
510(k)	K113514
Record published	2025-12-09
Record revised	2023-08-23 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 15 to 90 % RH; Handling environment temperature 5 to 40 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Storage environment temperature -25 to 70 °C
Sizes	Height 1.5 cm; width 8.5 cm; length 11 cm; weight 110 to 240 g

Catalogue Numbers

Catalogue numbers for Smartheart
Catalogue number	Size	Status
3.3	Belt – 32cm	In distribution
3.3	belt/ 32 cm	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
K113514	2012-02-22
K080047	2008-07-11
K063609	2007-09-12

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.