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510(k) Data Aggregation

    K Number
    K060936
    Device Name
    PARAGOLFER
    Manufacturer
    PARABASETEC, GMBH
    Date Cleared
    2006-08-07

    (124 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARABASETEC, GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Any individual who needs a power wheelchair and can not stand up on their own such as people with Paraplegia, Spina Bifida, Cerebral Paresis, Multiple Sclerosis, Muscular Dystrophy, and Polio. - Any individual to take part in sports activities requiring an upright position.
    Device Description
    The ParaGolfer Standup Wheelchair is a front wheel drive powered standup wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The ParaGolfer Standup Wheelchair has a "U" frame, controlled by a Curtis Instruments Controller, electronic regenerative disc brakes and Micro Motor.
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