# K160064: MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System

- Pathway: 510(k) (Abbreviated)
- Applicant: Infobionic, Inc.
- Decided: Mar 11, 2016 after 58 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: 9 generations back to K882803 (1988). 39 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100155: Truvue Wireless Ambulatory Ecg Monitoring System, Biomedical Systems Corp. (2010) Summary page 5.

## Most influential descendants
- 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

## Indications for use
MoMe® Kardia is intended to be used for: 1. Patients who experience transient symptoms 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 lightheadedness; 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 or interventional procedures who are indicated for outpatient arrhythmia monitoring. 5. ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports. MoMe® Kardia is contraindicated for: 1. MoMe® Kardia is contraindicated for those patients requiring attended, in-hospital monitoring for life threatening arrhythmias. Note: MoMe® Kardia does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.

Source page: https://510kreport.com/device/K160064
Methodology: https://510kreport.com/methodology