# K143359: CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector

- Pathway: 510(k) (Traditional)
- Applicant: Lifewatch Technologies, Ltd.
- Decided: Sep 11, 2015 after 291 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K963725 (1997). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110499: CG-5108 Act-3L Continuous Ecg Monitor and Arrhythmia Detector, Card Guard Scientific Survival, Ltd. (2011) Summary page 5.

## Most influential descendants
- K170565: LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L (2017), 0 descendants of its own

## Indications for use
The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alert triggered by an arrhythmia detection algorithm, or generates an alert manually triggered by the patient, and transmits the recorded data trans-telephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation. The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is intended to be prescribed for patients who have demonstrated a need for cardiac monitoring and are at low risk of developing life-threatening arrhythmias. Conditions where the system should not be used include patients likely to experience primary Ventricular Fibrillation or Ventricular Tachycardia and patients who have other co-morbid cardiovascular conditions where an arrhythmia could be potentially life threatening. This device has not been tested for and it is not intended for pediatric use.

Source page: https://510kreport.com/device/K143359
Methodology: https://510kreport.com/methodology