# K100155: Truvue Wireless Ambulatory Ecg Monitoring System

- Pathway: 510(k) (Abbreviated)
- Applicant: Biomedical Systems Corp.
- Decided: Apr 20, 2010 after 90 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 K882803 (1988). 38 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081257: CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia Detector, Card Guard Scientific Survival, Ltd. (2008) Summary page 1.
- K091971: Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) System, Corventis, Inc. (2009) Summary page 1.
- K090037: Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model Pocketecg, Medicalgorithmics SP Z.O.O. (2009) Summary page 1.

## Most influential descendants
- K160064: MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System (2016), 3 descendants of its own
- K230265: MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System (2023), 1 descendant of its own
- K250356: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) (2025), 0 descendants of its own
- K231276: SmartCardia 7L Platform (2023), 0 descendants of its own
- K131000: V-Patch System (2014), 0 descendants of its own

## Indications for use
1. The TruVueTM System is intended for use by patients who experience transient events that may suggest cardiac arrhythmia 2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation) 3. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadtedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath) 4. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring. 5. EGG data recorded by the device can be analyzed by other processing systems, such as the EMS Century Holter system to provide Halter style reports

Source page: https://510kreport.com/device/K100155
Methodology: https://510kreport.com/methodology