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510(k) Data Aggregation

    K Number
    K081665
    Device Name
    MILLENIUM II
    Manufacturer
    NEXT MOBILITY, LLC
    Date Cleared
    2008-06-27

    (14 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEXT MOBILITY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Millenium II wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.
    Device Description
    The Millenium II wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.
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    K Number
    K080880
    Device Name
    RTM AND OVAL
    Manufacturer
    NEXT MOBILITY, LLC
    Date Cleared
    2008-04-09

    (9 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEXT MOBILITY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RTm and Oval wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.
    Device Description
    The RTm and Oval wheelchairs are mechanical wheelchairs.
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