# K133753: Mome Ecg Continuous Detection and Arrhythmia Detector

- Pathway: 510(k) (Traditional)
- Applicant: Infobionic, Inc.
- Decided: Sep 19, 2014 after 284 days
- Product code: QYX (Outpatient Cardiac Telemetry)
- 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: 7 generations back to K963725 (1997). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072558: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005, Cardionet, Inc. (2007). Our reading of the summary gave K072588, FDA’s number for Performax SE Total Face Mask (Respironics Inc., Sleep & Home Respiratory Group). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CardioNet ECG Monitoring and Arrhythmia Detection System”.
- K093288: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Cardionet, Inc. (2010) Summary page 6.
- K121197: Bodyguardian System Bodyguardian Control Unit Bodyguardian Connect, Preventice, Inc. (2012) Summary page 6.

## Most influential descendants
- K152491: MoMe Software Platform (2015), 0 descendants of its own

## Indications for use
The MoMe™ Continuous ECG Monitor and Arrhythmia Detector System (MoMe™ System) is indicated for: 1. Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia. 2. Patients with dizziness or lightheadedness. 3. Patients with palpitations. 4. Patients with syncope of unknown etiology. 5. Patients who require monitoring for non-life threatening arrhythmias, such as atrial fibrillation, other supraventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block. 6. Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias. 7. Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease. 8. Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias. 9. Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation. The MoMe™ System is contraindicated for: 1. Patients with potentially life threatening arrhythmias who require in-patient monitoring. 2. Patients who the attending physician thinks should be hospitalized. 3. Patients with implanted pacemakers, ICDs, neurostimulators and/or body worn medical devices such as insulin pumps. Intended Population: For Adult Use Only. The MoMe™ Continuous ECG Monitor and Arrhythmia Detector is intended for patients who are 22 years and older.

Source page: https://510kreport.com/device/K133753
Methodology: https://510kreport.com/methodology