# K212883: ers2 - ergoline Rehabilitation System

- Pathway: 510(k) (Traditional)
- Applicant: Ergoline GmbH
- Decided: Jul 15, 2022 after 308 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: 3 generations back to K003576 (2001). 4 ancestors in all.
1 later device descends 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)
- K050778: Telerehad 2004, Scottcare (2005) Summary page 4.

## Most influential descendants
- K250259: TeleRehab Aermos Cardiopulmonary Rehabilitation (2025), 0 descendants of its own

## Indications for use
The ers2 — ergoline Rehabilitation System is a device for recording of a single-channel, bipolar surface ECG (frontal plane) acquired with two ECG electrodes. The ECG is transmitted to the ers2 software where it is processed for heartrate calculation, displayed for visual QRS complex assessment and to control the training load for a patient’s rehabilitation or preventive training activities. The ers2 system is not intended to be used to detect or diagnose cardiac conditions (e.g. arrhythmias, ST-elevation, etc. pp). The signal is acquired on the intact skin of adult patients. The medical device is intended for use in professional healthcare Institutions for inpatient and outpatient care.

Source page: https://510kreport.com/device/K212883
Methodology: https://510kreport.com/methodology