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

    FREEDOM SCIENCES MOTION CONTROL MODULE VERSION 1.5

    K Number: K091723 · Decision Jul 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    550
    Applicant Total
    2
    Review Days
    25

    Basic Information

    Device Name
    FREEDOM SCIENCES MOTION CONTROL MODULE VERSION 1.5
    K Number
    K091723
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    FREEDOM SCIENCES, LLC
    Date Received
    June 11, 2009
    Decision Date
    July 6, 2009
    Product Code
    ITI
    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
    ITI Wheelchair, Powered

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    Other Clearances by FREEDOM SCIENCES, LLC

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    K073330 FREEDOM SCIENCES MOTION CONTROL MODULE (MCM)