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510(k) Data Aggregation

    K Number
    K993443
    Device Name
    RTD ARM ASSISTIVE ROBOTIC DEVICE
    Date Cleared
    1999-12-17

    (66 days)

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

    REHABILITATION TECHNOLOGIES DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RTD Arm permits persons with severe disabilities to manipulate objects in their personal environment and thus to establish a greater measure of functional independence. The client population for this device includes individuals with - very limited or complete absence of bilateral upper extremity function. - lower extremity impairment requiring the use of a power wheelchair, and - intact cognitive and visual perceptual ability. The medical diagnoses of the target user populations include high-level quadriplegia, neuromuscular disabilities, cerebral palsy, and other congenital disabilities such as spina bifida, or arthrogryposis. In addition, individuals with other types of disabilities resulting in permanent or temporary impairment to upper extremity function may also benefit from use of the RTD Arm as an aid in performing manipulation of objects. These disabilities include paraplegia, stroke, severe head injury, multiple broken bones, and severe rheumatoid arthritis, among others. The RTD Arm may be purchased as an over-the-counter device.
    Device Description
    The RTD Arm is a wheelchair-mountable powered electromechanical arm which permits persons with severe disabilities to manipulate objects in their personal environment. The RTD Arm is controlled through standard switch-based input devices and can be mounted on either side of most powered wheelchairs. At full reach (48 inches), the RTD Arm can lift four pounds and, as the arm is retracted, the lifting capacity becomes proportionally greater. The arm has 4 degrees of freedom to enable the arm to access an obiect, which is augmented by the two planar degrees of freedom of the wheelchair. Using the RTD Arm input control device, the operator retrieves an object by quiding the arm one ioint at a time until it is in the correct position. The operator then activates the gripper to grasp the object and directs the arm to the desired end point. The arm can be operated by the user's existing chair switch mechanism (e.g. joystick, head pad sensor, or sip and puff), with wiring modifications, or with the 8 Position Joystick or Keypad provided with the arm. The arm includes four 24V motors controlled by a solid state motor controller powered by the wheelchair battery. Wheelchair installation is performed using a mounting bracket, which secures the unit to the chair frame directly behind the front caster. The RTD Arm includes the following primary safety features: Gripper strength limit. Iimited to 5 pounds per square inch. Slip clutches. All joints include an in-line, maintenance-free slip clutch at each motor which begin to slip when 5 pounds per square inch is exerted by the arm. Low center of gravity. The center of gravity of the arm is kept very low on the wheelchair by mounting it under the seat behind the front wheels. In most cases, the center of gravity of the overall chair and arm is lower than without the arm.
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