AfibAlert

The AfibAlert® is a cardiac event recorder capable of recording and storing ~five hundred 45-second events in solid-state non-volatile memory. AfibAlert® allows patients who have been…

Registry build 21.09.26

The AfibAlert® is a cardiac event recorder capable of recording and storing ~five hundred 45-second events in solid-state non-volatile memory. 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 four ways: (I) via the two thumb electrodes, (2) by placement on the chest, (3) by applying wrist electrodes or (4) applying two sticky electrodes as instructed by their physician. 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 appropriate LED (light emitting diode) is illuminated to indicate the presence or absence of AF. If AF is indicated, or concerning symptoms are present, the patient can either use a Bluetooth connection to a smart device or use a USB connection to a computer to transfer their ECG data to be viewed and/or shared with their physician.

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
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 2020-07-01
Record revised 2022-10-17 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Packaging Box of 10, box of 50
Distribution end date 2022-10-16

Catalogue Numbers

Catalogue numbers for AfibAlert
Catalogue number Size Status
V1.5 Withdrawn

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