BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MyoCycle MC-2 (Home / Home + / Pro / Pro +)

    K Number: K213925 · Decision Apr 25, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    60
    Applicant Total
    2
    Review Days
    130

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    Basic Information

    Device Name
    MyoCycle MC-2 (Home / Home + / Pro / Pro +)
    K Number
    K213925
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5810
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Myolyn, LLC
    Date Received
    December 16, 2021
    Decision Date
    April 25, 2022
    Product Code
    GZI
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GZI Stimulator, Neuromuscular, External Functional

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    Other Clearances by Myolyn, LLC

    K Number Device Name
    K170132 MyoCycle Home, MyoCycle Pro