AfibAlert / Hom Ecg+

The hom ecg+ / AfibAlert® is a cardiac event recorder capable of recording and storing approximately thirty 45-second events in solid-state non-volatile memory. The hom ecg+ / AfibAlert®…

Registry build 21.09.26

The hom ecg+ / AfibAlert® is a cardiac event recorder capable of recording and storing approximately thirty 45-second events in solid-state non-volatile memory. The hom ecg+ / AfibAlert® allows patients who have been diagnosed with, or are susceptible to developing atrial fibrillation (AF) to take periodic readings with a computerized rhythm monitor. The system was developed for the patient that is at risk or has been previously diagnosed with AF, has a history of heart bypass, ablation, or other cardiac abnormality, or is on heart (anti-arrhythmic) medication. In these cases, detecting and determining AF early can potentially reduce the risk of heart attack and stroke. The device can record a single channel of ECG data in three ways: (I) via the two thumb electrodes, (2) by applying wrist electrodes or (3) applying two sticky electrodes as instructed by their health care practitioner. In each case, the patient initiates the recording. An individual recording will take ~45 seconds. Immediately following data acquisition, an internal AF algorithm is used to analyze the patient’s rhythm. The built-in graphical LCD display indicates the presence or absence of AF. If ECG data is present (whether or not AF is indicated) the device uses an internal cellular module to transfer the ECG data to the cloud to be viewed and/or shared with their physician or health care practitioner using either company developed or third party developed internet based software program(s).

6manufacturers in China registered for this device type
1catalogue number

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 AfibAlert / hom ecg+
Listed by Lohman Technologies, LLC, United States
FDA product code DXH
Device type Transmitters And Receivers, Electrocardiograph, Telephone
Device class Class 2
Regulation 21 CFR 870.2920
Establishment Manufacturer
510(k) K052767
Record published 2022-09-27

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries serial number

Catalogue Numbers

Catalogue numbers for AfibAlert / hom ecg+
Catalogue number Size Status
V2.0 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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer