# K152491: MoMe Software Platform

- Pathway: 510(k) (Traditional)
- Applicant: Infobionic, Inc.
- Decided: Dec 17, 2015 after 107 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). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133753: Mome Ecg Continuous Detection and Arrhythmia Detector, Infobionic, Inc. (2014) Summary page 4.

## Indications for use
The MoMe® Software Platform is intended to be used for patients 22 years and older that have one or more of the following conditions: 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® Software Platform 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.

Source page: https://510kreport.com/device/K152491
Methodology: https://510kreport.com/methodology