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.
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
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"
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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
DXH
Product Code Name
Transmitters And Receivers, Electrocardiograph, Telephone
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
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
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |