AfibAlert / hom ecg+

Primary DI
00860003939734
Brand
AfibAlert / hom ecg+
Company
LOHMAN TECHNOLOGIES, LLC
Model
V2.0
Catalog number
790.102.200
Device description
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).
Published
2022-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DXHTransmitters And Receivers, Electrocardiograph, Telephone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052767000AFIBALERT ATRIAL FIBRILLATION DETECTORLechnologies Research, Inc.2006-06-23DXH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003939734PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003939734008600039397348600039397340860003939734

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, home-useA device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080381900
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003939703AfibAlertV1.5790.0102.0012020-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
05419980589309FibriCheckQompiumDXH2026-05-06
05419980589316FibriCheckQompiumDXH2026-05-06
05419980589323FibriCheckQompiumDXH2026-05-06
05419980589347FibriCheckQompiumDXH2026-05-06
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DXH2026-02-11
00198953107263MACGe Medical Systems Information Technologies, Inc.DXH2026-01-27
07290008960380SmartheartSHL TELEMEDICINE INTERNATIONAL LTD.DXH2025-12-09
04719872981756QT ECGQt Medical, Inc.DXH2025-05-12
B353UB22511UbiqVue HolterLifesignals, Inc.DXH2025-04-22
B353UA2251R1UbiqVueLifesignals, Inc.DXH2025-04-22
00195278421456CAMGE Medical Systems Information Technologies, Inc.DXH2025-04-07
00812324000297GEMS Mobile ECGCardioComm Solutions, IncDXH2025-03-20
B210AC0290K1000Alivecor, Inc.DXH2025-03-18
00840682144322MACGE Medical Systems Information Technologies, Inc.DXH2025-03-13
00860006382308SENSINEL™ CPM REPLACEMENT ADHESIVE PADAnalog Devices, Inc.DXH2025-03-13
00860006382315SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2025-03-13
00860006382322SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DXH2025-03-13
00860006382339SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DXH2025-03-13
00860006382346SENSINEL™ CPM ALIGNMENT TOOLAnalog Devices, Inc.DXH2025-03-13
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.DXH2025-03-13
08908013617128Frontier X PlusFOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITEDDXH2025-02-07
00850043907046Zio ECG Utilization Software (ZEUS) SystemIRHYTHM TECHNOLOGIES, INC.DXH2024-07-26
04719872981527QT ECGQt Medical, Inc.DXH2024-07-08
04719872981534QT ECGQt Medical, Inc.DXH2024-07-08
00856298006428EZLink-RSCOTTCARE CORPORATION, THEDXH2024-05-23