BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    KNEEKG

    K Number: K091000 · Decision Oct 26, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    201

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    Basic Information

    Device Name
    KNEEKG
    K Number
    K091000
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5360
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Emovi
    Date Received
    April 8, 2009
    Decision Date
    October 26, 2009
    Product Code
    LXJ
    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
    LXJ Interactive Rehabilitation Exercise Devices

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