Identity
- Trade Name
- AfibAlert FDA UDI
- Generic Name
- Electrocardiograph, home-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- V1.5 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 790.0102.001 FDA UDI
- Primary DI / UDI-DI
- 00860003939703 FDA UDI
- 510(k) Number
- K052767 FDA UDI
- FDA Product Code
- DXH FDA UDI
- GMDN Term
- Electrocardiograph, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2920 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
AfibAlert by Lohman Technologies, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K052767 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lohman Technologies, Llc
Sources (1)
- FDA UDI 69645e0e-0475-4100-af88-6b43f04b4866 36 fields · synced May 30, 2026