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510(k) Data Aggregation

    K Number
    K183152
    Device Name
    Phoenix
    Date Cleared
    2019-04-17

    (154 days)

    Product Code
    Regulation Number
    890.3480
    Why did this record match?
    Applicant Name (Manufacturer) :

    US Bionics, Inc. (DBA suitX)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Phoenix orthotically fits to the lower limbs and trunk. The device is intended to enable individuals with spinal cord injury at levels T4 to L5 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. This device is not intended for sports or stair climbing.
    Device Description
    The Phoenix™ is a wearable, powered exoskeleton that assists a trained user to sit, stand, walk, and turn. The Phoenix consists of a pair of motorized leg braces coupled to a torso module, a lithium-ion battery pack, a main controller unit, and a wireless user interface attached to the handle of an assistive device (such as a crutch, walker, or parallel bars), control software, and mobile Android tablet hosting a mobile app. The Phoenix dimensions, such as spine length, torso hip width, femur length, femur bracket, tibia length, tibia bracket, and foot plate length can be adjusted individually. The Phoenix is coupled to the user via soft-good components (i.e. shoulder straps, waist pads, thigh straps, and shin pads), which can be adjusted to accommodate various users' dimensions.
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