# K173969: Medicalgorithmics Unified Cardiac Rehabilitation System

- Pathway: 510(k) (Abbreviated)
- Applicant: Medicalgorithmics S.A.
- Decided: Jul 11, 2018 after 194 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: 7 generations back to K882803 (1988). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124060: Medical Gorithmics Unified Arrhythmia Diagnostic System, Medicalgorithmics S.A. (2013) Summary page 5.
- K041607: Quinton Q-TE; RMS, Quinton Cardiology, Inc. (2004) Summary page 5.

## Indications for use
PocketECG CRS is intended to be used for: 1. Cardiac monitoring of patients undergoing a cardiac rehabilitation program. Its main feature is patient monitoring during previously planned training sessions and training assistance to achieve desired intensity and duration of workout. Training session parameters such as heart rate threshold, session duration (time intervals and number of repetitions) are defined by the physician for each patient individually. Additionally, the transmitter allows continuous ECG monitoring between trainings, during patient daily activities. 2. All patients hospitalized with a primary diagnosis of an acute myocardial infarction (MI) or chronic stable angina (CSA), or who during hospitalization have undergone coronary artery bypass graft (CABG) surgery, a percutaneous coronary intervention (PCI), cardiac valve surgery, or cardiac transplantation, referred to an early outpatient cardiac rehabilitation or secondary prevention (CR) program. 3. All patients evaluated in an outpatient setting who within the past 12 months have experienced an acute myocardial infarction (MI), coronary artery bypass graft (CABG) surgery, a percutaneous coronary intervention (PCI), cardiac valve surgery, or cardiac transplantation, or who have chronic stable angina (CSA) and have not already participated in an early outpatient cardiac rehabilitation or secondary prevention (CR) program for the qualifying event or diagnosis, referred to such a program. 4. Patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease; 5. PocketECG CRS can be used to monitor the training session in hospital, rehabilitation center or physicians office under supervision of qualified staff.

Source page: https://510kreport.com/device/K173969
Methodology: https://510kreport.com/methodology