AfibAlert - The AfibAlert® is a cardiac event recorder - LOHMAN TECHNOLOGIES, LLC

Duns Number:080381900

Device Description: The AfibAlert® is a cardiac event recorder capable of recording and storing ~five hundred 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.

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More Product Details

Catalog Number

790.0102.001

Brand Name

AfibAlert

Version/Model Number

V1.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 16, 2022

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,K052767,K052767

Product Code Details

Product Code

DXH

Product Code Name

Transmitters And Receivers, Electrocardiograph, Telephone

Device Record Status

Public Device Record Key

69645e0e-0475-4100-af88-6b43f04b4866

Public Version Date

October 17, 2022

Public Version Number

4

DI Record Publish Date

July 01, 2020

Additional Identifiers

Package DI Number

00860003939710

Quantity per Package

10

Contains DI Package

00860003939703

Package Discontinue Date

October 16, 2022

Package Status

Not in Commercial Distribution

Package Type

Box

"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