AfibAlert / hom ecg+ - The hom ecg+ / AfibAlert® is a cardiac event - LOHMAN TECHNOLOGIES, LLC

Duns Number:080381900

Device Description: The hom ecg+ / AfibAlert® is a cardiac event recorder capable of recording and storing ap 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).

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More Product Details

Catalog Number

790.102.200

Brand Name

AfibAlert / hom ecg+

Version/Model Number

V2.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K052767

Product Code Details

Product Code

DXH

Product Code Name

Transmitters And Receivers, Electrocardiograph, Telephone

Device Record Status

Public Device Record Key

0b8c343b-1344-4f91-81e7-c4b358770256

Public Version Date

October 05, 2022

Public Version Number

1

DI Record Publish Date

September 27, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LOHMAN TECHNOLOGIES, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1