# K153477: EMMa Electronic Monitoring Management

- Pathway: 510(k) (Traditional)
- Applicant: Vitasystems GmbH
- Decided: May 25, 2016 after 175 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: 2 generations back to K081444 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092947: Telesentry, Model TS01, Scottcare Corporation (2010) Summary page 5.

## Indications for use
The EMMa system is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest non-lethal cardiac arrhythmia to support and possibly improve an ongoing treatment by the patient’s physician. Data received from battery powered ambulatory monitoring devices, triggered by an arrhythmia detection algorithm or manually by the patient, are stored and forwarded to licensed physician for review. Contraindications of Use: - Patients with potentially life-threatening arrhythmias who require inpatient monitoring. - Patients who the attending physician thinks should be hospitalized. The software is not intended to be used to trigger emergency treatment or alert chains.

Source page: https://510kreport.com/device/K153477
Methodology: https://510kreport.com/methodology