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

    POWER DRIVE CHAIR, MODEL: TMM6

    K Number: K091043 · Decision May 11, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    28

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    Basic Information

    Device Name
    POWER DRIVE CHAIR, MODEL: TMM6
    K Number
    K091043
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3690
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Transmotion Medical, Inc.
    Date Received
    April 13, 2009
    Decision Date
    May 11, 2009
    Product Code
    INK
    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
    INK Stretcher, Wheeled, Powered

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