# K113187: Avivo Mobile Patient Management

- Pathway: 510(k) (Abbreviated)
- Applicant: Corventis, Inc.
- Decided: Jan 4, 2012 after 65 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- 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). 23 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083287: Avivo Mobile Patient Management System, Corventis, Inc. (2009) Summary page 1.
- K090696: Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System, Corventis, Inc. (2009) Summary page 1.
- K091971: Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) System, Corventis, Inc. (2009) Summary page 1.
- K111917: Nuvant, Mobile Cardiac Telemetry, Corventis, Inc. (2011) Summary page 1.
- K042113: Zoe Fluid Status Monitor, Noninvasive Medical Technologies, LLC (2004) Summary page 1.

## Most influential descendants
- K172510: µCor Heart Failure and Arrhythmia Management System (2018), 1 descendant of its own
- K142087: Cova Monitoring System (2015), 1 descendant of its own
- K190939: ZOLL Arrhythmia Management Sysyem (2019), 0 descendants of its own
- K160899: CoVa Monitoring System 2 (2017), 0 descendants of its own
- K153160: AVIVO Mobile Patient Management (MPM) System (2016), 0 descendants of its own

## Indications for use
The AVIVO Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for patients: * with fluid management problems * taking diuretic medication * living with heart failure * living with end-stage renal disease * suffering from recurrent dehydration * who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders. The AVIVO Mobile Patient Management System also monitors, derives and displays: * ECG * Heart Rate (including HR variability) * Activity * Posture * Respiration rate (including RR variability) * Body fluid status

Source page: https://510kreport.com/device/K113187
Methodology: https://510kreport.com/methodology
