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

    HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2

    K Number: K093946 · Decision Mar 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    35
    Applicant Total
    17
    Review Days
    89

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    Basic Information

    Device Name
    HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2
    K Number
    K093946
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5150
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hoveround Corp.
    Date Received
    December 23, 2009
    Decision Date
    March 22, 2010
    Product Code
    ILK
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ILK Transport, Patient, Powered

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