Who else makes this device?

Name: ECG Check
Brand: ECG Check

Cardiovascular › MonitoringTransmitters And Receivers, Electrocardiograph, Telephone

ECG Check

The ECG Check is intended for self-testing by patients at home. This 1-lead cardiac monitor allows remote patients to display and transmit their EGG data to medical professionals via a…

Registry build 21.09.26

The ECG Check is intended for self-testing by patients at home. This 1-lead cardiac monitor allows remote patients to display and transmit their EGG data to medical professionals via a communication device to a remote server. Specifically, the EGG Check is indicated for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms: * Skipped Beats * Pounding Heart (Palpitations) * Heart Racing or Irregular Pulse * Lightheadedness or Faintness * History of Arrhythmias Prescription

6manufacturers in China registered for this device type

1catalogue number

2510(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 ECG Check
Listed by	Cardiac Designs, LLC, United States
FDA product code	DXH
Device type	Transmitters And Receivers, Electrocardiograph, Telephone
Device class	Class 2
Regulation	21 CFR 870.2920
510(k)	K122184
Record published	2016-09-28
Record revised	2021-11-10 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Over the counter	Yes
Label carries	manufacturing date, serial number
Storage	Storage environment humidity 30 to 85 % RH; Storage environment temperature -4 to 149 °F

Catalogue Numbers

Catalogue numbers for ECG Check
Catalogue number	Size	Status
ECG01-U		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
K170506	2017-10-02
K122184	2013-02-14

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.