# K050778: Telerehad 2004

- Pathway: 510(k) (Traditional)
- Applicant: Scottcare
- Decided: Apr 13, 2005 after 16 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- 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 K003576 (2001). 3 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K895719: Telerehab System for Cardiac Rehabilitation, Scottcare Corp. (1990) Summary page 1.
- K041607: Quinton Q-TE; RMS, Quinton Cardiology, Inc. (2004) Summary page 1.

## Most influential descendants
- K212883: ers2 - ergoline Rehabilitation System (2022), 1 descendant of its own
- K250259: TeleRehab Aermos Cardiopulmonary Rehabilitation (2025), 0 descendants of its own

## Indications for use
This device is intended to acquire and condition the ECG signal from a patient so that it can be transmitted via radio frequency (WMTF) with a Stickman telemetry transmitter to a workstation in a hospital or clinical setting where the ECG is displayed and analyzed. This device is for use with ambulatory adult patients, which need monitoring while undergoing cardiac or pulmonary rehabilitation. The data output from monitoring is viewed and stored on a workstation for tracking of the patients' progress through rehabilitation or other monitoring. Patient demographics, exercise protocol and medical information can be entered via a variety of commercially available wireless input devices or automatically through an HL-7 hospital network interface. A database can be created for use with an Outcomes program.

Source page: https://510kreport.com/device/K050778
Methodology: https://510kreport.com/methodology