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510(k) Data Aggregation

    K Number
    K213925
    Device Name
    MyoCycle MC-2 (Home / Home + / Pro / Pro +)
    Manufacturer
    Myolyn, LLC
    Date Cleared
    2022-04-25

    (130 days)

    Product Code
    GZI
    Regulation Number
    882.5810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Myolyn, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K170132
    Device Name
    MyoCycle Home, MyoCycle Pro
    Manufacturer
    MYOLYN, LLC
    Date Cleared
    2017-04-25

    (98 days)

    Product Code
    GZI
    Regulation Number
    882.5810
    Why did this record match?
    Applicant Name (Manufacturer) :

    MYOLYN, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MyoCycle is intended for general rehabilitation for: 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Maintaining or increasing range of motion
    Device Description
    The MyoCycle is a stationary FES cycle ergometer which is composed of: 1. a motorized cycle ergometer 2. an FES controller / stimulator 3. a stimulation cable which connects the controller / stimulator to cutaneous electrodes (at maximum 12 cutaneous electrodes for 6 channels) 4. cutaneous electrodes This system allows a person with impaired lower extremity movement to undertake cycle ergometry both actively (utilized FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor). The electric motor inside the MyoCycle ensures that the pedals always rotate at 35 revolutions per minute (r/min) (isokinetic cycling), so it automatically assists or resists the patient, depending on the magnitude and direction of the torque applied to the crank by the patient. The system software operates in two modes: 1. Pro mode allows for multiple users by storing unique user data that can be accessed by a unique user identification code 2. Home mode only stores data for one user
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