# K250356: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)

- Pathway: 510(k) (Traditional)
- Applicant: Infobionic, Inc.
- Decided: Jul 29, 2025 after 172 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: 11 generations back to K882803 (1988). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230265: MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System, Infobionic, Inc. (2023) Summary page 5.
- K153473: Braemar Telemetry Patch System, Braemar Manufacturing, LLC (2016) Summary page 5.

## Indications for use
MoMe ARC® is indicated 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 ARC® is contraindicated for: 1. MoMe ARC® is contraindicated for those patients requiring attended, in hospital monitoring for life threatening arrhythmias. 2. MoMe ARC® is not intended for use on infants weighing less than 10kg (22lbs.). Clinical judgement is necessary to determine if the MoMe ARC® is appropriate for specific pediatric patients. 3. The patch configuration of the MoMe ARC® is contraindicated for monitoring QT intervals for patients taking Class III antiarrhythmic drugs. Note: MoMe ARC® does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.

Source page: https://510kreport.com/device/K250356
Methodology: https://510kreport.com/methodology