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510(k) Data Aggregation

    K Number
    K123769
    Device Name
    ZX-I POWER ADD ON
    Manufacturer
    Date Cleared
    2013-05-10

    (154 days)

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

    SPINERGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ZX-1 is intended to provide enhanced mobility to disabled persons who are capable of operating a powered and manual wheelchair, by providing powered mobility to manual wheelchairs.
    Device Description
    The ZX-1 Power Add On is a light duty, power add-on device with the purpose of delivering powered mobility to a manual wheelchair. The device easily attaches/detaches to the frame of a manual wheelchair. The engagement between the ZX-1 and the manual wheelchair is accomplished without the need for hardware or other fixed attachment devices. The user remains seated in their manual wheelchair and performs a simple maneuver to attach the ZX-1 to their manual wheelchair. Once securely attached to the ZX-1, the user negotiates the speed and direction of their wheelchair by using a VR2 joystick controller attached to the arm rest of the ZX-1. The device consists primarily of a stainless steel base with drive wheels, a power module with joystick, two drive motors, a connector mechanism, two armrests and an anti-tilt assembly. It functions by connecting to the host manual wheelchair rear camber tube. Once the connection is made, the linear actuator lifts the manual wheelchair rear wheels slightly off the ground and onto the stainless steel base with drive wheels. Power to the drive motors is supplied by use of the joystick which is used to engage wheelchair motion and steer the chair. During use, the ZX-1 offers forward, reverse and 360 degree turning maneuverability. The user is able to adjust the speed setting to meet their needs and level of comfort.
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