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510(k) Data Aggregation

    K Number
    K120783
    Device Name
    ABLE-X
    Manufacturer
    IM-ABLE LTD
    Date Cleared
    2012-06-20

    (97 days)

    Product Code
    ION
    Regulation Number
    890.5370
    Why did this record match?
    Product Code :

    ION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Able-X is indicated for use by stroke patients undergoing upper limb rehabilitation to facilitate: : - Stroke rehabilitation by muscle re-education - Maintaining or increasing range of motion
    Device Description
    The Able-X is an exercise system that uses virtual reality to promote therapeutic bilateral movement exercises through use of a wireless hand held game controller and computer games. The Able-X is comprised of a lightweight polymer handlebar with a wireless game controller mounted at one end and a fixed hand vertical hand grip at the other end of the bar. The wireless controller communicates via a USB receiver dongle to a computer installed with therapeutic exercise games. Game play of the therapeutic exercises is controlled through the game controller and displayed in real-time on the computer screen. The Able-X therapeutic exercise games are provide on a CD or can be downloaded directly through the internet. The Able-X does not include a separate console and is intended to be operated directly through a user supplied computer that meets minimum processing and operating system requirements.
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