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510(k) Data Aggregation

    K Number
    K212883
    Device Name
    ers2 - ergoline Rehabilitation System
    Manufacturer
    ergoline GmbH
    Date Cleared
    2022-07-15

    (308 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    ergoline GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended 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.
    Device Description
    The Ergoline Rehabilitation System 2 consists of a) software (ers2) and b) hardware (ers2 1CH ECG Telemetry system). a) The software system runs on a PC and is used by therapists to monitor, control and document the training sessions of rehabilitation patients (e.g. in endurance and strength training), whereby the patient can train on different devices or free without the support of devices. Free training can, for example, be performed on strength training equipment or through gymnastic exercises. The central component of the ers2 system is a PC with an MS Windows operating system and special software which runs the training programs. The training ergometers are connected to the PC system via control lines or a WiFi interface. All data are shown on one to three 22-inch TFT monitors; up to eight patients can be displayed and supervised on each monitor. The ers2 software receives the patient's physiological parameters from the ers2 1CH ECG Telemetry System and uses them for display on the monitor as well as to control the training devices. Data are transferred between the wireless ergoline ECG transmitter and PC via Bluetooth©. b) Via the applied part, the ers2 1CH ECG Transmitter acquires a single-channel, bipolar raw ECG signal and sends it to a medical application software or other ME equipment by radio transmission. The ers2 1CH ECG transmitter is an ME device powered from integrated, exchangeable, rechargeable batteries These are the components of the ers2 1CH ECG Telemetry system: . ers2 1CH ECG Transmitter consisting of enclosure, ECG amplifier, radio transmission module, micro-controller with firmware and device connection of the ECG adapter, is worn on the body near the heart and affixed to the ETS1 adapter no skin contact, accessible part, type CF. . The ers2 1CH ECG adapter (applied part, ECG patient connection) with device socket for connection to the ECG transmitter and device socket for connection to the patient connection (ECG electrode), is worn on the body near the heart, type CF. . ers2 ECG receiver, receives the ECG signals transmitted by radio. Permanently connected to USB port of a Windows PC. Operated outside patient environment, accessible part, protection class II.
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    K Number
    K112121
    Device Name
    ERGOSELECT/GE
    Manufacturer
    ERGOLINE GMBH
    Date Cleared
    2012-10-31

    (464 days)

    Product Code
    ISD
    Regulation Number
    890.5360
    Why did this record match?
    Applicant Name (Manufacturer) :

    ERGOLINE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.
    Device Description
    The Ergoselect is the result of long-standing experience and its consequent implementation. The system is convincing thru the optimal, and therefore, cost-effective configuration of the ergometer according to in medical ergometer specific requirements. Modern computer control allows Stand-alone operation of the ergometer as well as comfortable control via external devices (PC system). Ergoline Ergoselect / GE measures data concerning patients procedures and in conjunction with ergometer bicycles procedures. Ergoselect / GE ergometer includes following models (P/K versions): Ergoselect 50, Ergoselect 100 / 200, Ergoselect 600, Ergoselect 1000, Ergoselect 1200, Optibike 50 med, Optibike med.
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    K Number
    K053078
    Device Name
    ERGOSELECT 100 K/P, ERGOSELECT 200 K/P
    Manufacturer
    ERGOLINE GMBH
    Date Cleared
    2006-04-27

    (176 days)

    Product Code
    ISD
    Regulation Number
    890.5360
    Why did this record match?
    Applicant Name (Manufacturer) :

    ERGOLINE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.
    Device Description
    The Ergoselect 100 K/P; Ergoselect 200 K/P ergometer has been designed to meet the medical and ergonomic requirements for an efficient and relevant stress test of the cardiovascular system. Modern computer control allows Stand-alone operation of the ergometer as well as comfortable control via external devices (PC system). Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P ergometer measures data concerning patients procedures and in conjunction with ergometer bicycles procedures. The ergometry system Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P consists out of the following components: Basic unit: Ergoselect 100: Ergoselect 200 Control panel type P / K Control unit: Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P ergometer measures data concerning patients procedures and in conjunction with ergometer bicycles procedures.
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