# K041607: Quinton Q-TE; RMS

- Pathway: 510(k) (Abbreviated)
- Applicant: Quinton Cardiology, Inc.
- Decided: Jul 16, 2004 after 31 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003576 (2001). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003576: Q-Tel RMS (Rehabilitation Management System), Model 000503, Quinton, Inc. (2001) Summary page 1.

## Most influential descendants
- K050778: Telerehad 2004 (2005), 2 descendants of its own
- K212883: ers2 - ergoline Rehabilitation System (2022), 1 descendant of its own
- K250259: TeleRehab Aermos Cardiopulmonary Rehabilitation (2025), 0 descendants of its own
- K173969: Medicalgorithmics Unified Cardiac Rehabilitation System (2018), 0 descendants of its own

## Recalls of this device
- Mar 18, 2020 · Class II · Z-1818-2020: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

## Indications for use
The device is intended to acquire and transmit electrocardiograph (ECG) data by means of a radio-frequency transmitter worn by individual patients in a hospital or clinical setting to a central monitor where it is received, displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change. The device is to be used on ambulatory adult populations where monitoring is prescribed while undergoing exercise rehabilitation. Multiple central receivers may be used and connected to a local area network. Specified wireless data entry devices may be connected to the system via a wireless access point and be used as a station for entry of patient session data. Optional workstation(s) may be connected to the system via a network for entering and viewing patient demographic and rehab session data. The workstation may also be used for tracking patient progress in cardiac rehab and displaying non-real-time waveforms and alarms. ECG analysis may include 12-lead EGG interpretation. Patient demographics, exercise prescription, scheduling information, and collected data can be ported to an outcomes management program.

Source page: https://510kreport.com/device/K041607
Methodology: https://510kreport.com/methodology