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510(k) Data Aggregation

    K Number
    K151199
    Device Name
    SmartDrive Wheelchair Power Assist
    Manufacturer
    MAX MOBILITY, LLC
    Date Cleared
    2015-07-30

    (86 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAX MOBILITY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartDrive MX2 Wheelchair Power Assist is intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users, including pediatrics. It is intended to be used by users capable of operating and maneuvering a powered and manual wheelchair.
    Device Description
    SmartDrive MX2 Wheelchair Power Assist
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    K Number
    K113621
    Device Name
    SMARTDRIVE WHEELCHAIR POWER-ASSIST
    Manufacturer
    MAX MOBILITY, LLC
    Date Cleared
    2012-07-06

    (211 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAX MOBILITY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartDrive is intended to provide power-assist to manual wheelchairs, empowering disabled persons, including pediatrics, capable of operating a powered and manual wheelchair by providing a means of enhanced mobility.
    Device Description
    Not Found
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    K Number
    K102837
    Device Name
    HIROLLER ELEVATING WHEELCHAIR
    Manufacturer
    MAX MOBILITY, LLC
    Date Cleared
    2010-12-23

    (85 days)

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

    MAX MOBILITY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HiRoller Elevating Wheelchair is a product that allows wheelchair users to raise and lower their seat height while seated in the wheelchair.
    Device Description
    Not Found
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