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510(k) Data Aggregation

    K Number
    K202979
    Device Name
    MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
    Manufacturer
    Lode B.V.
    Date Cleared
    2020-12-21

    (82 days)

    Product Code
    ISD
    Regulation Number
    890.5360
    Type
    Abbreviated
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lode B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended to be used as a stress test device in a medical environment. The main goal of the devices is to create reproducible stress tests. With cycling ergometers typically workload (watt) is imposed. This product is designed both for manual operation and for control by external software. This device will be used in conjunction with another medical device to obtain other important physiological data, allowing a physician to evaluate a test subjects physical status.

    Device Description

    MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (MR Ergometers) and does not contain information about acceptance criteria or a study proving that the device meets such criteria. It primarily focuses on the FDA's regulatory review and determination of substantial equivalence for the device.

    Therefore, I cannot provide the requested information based on the given input.

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