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510(k) Data Aggregation

    K Number
    DEN120016
    Device Name
    DEKA ARM SYSTEM
    Date Cleared
    2014-05-09

    (693 days)

    Product Code
    Regulation Number
    890.3450
    Why did this record match?
    Product Code :

    PAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DEKA Arm System consists of a prosthetic arm and accessories, which are used by a certified prosthetist to create a full upper extremity prosthesis indicated for individuals, age 18 years and older, who have partial or full upper limb amputations or congenital defects. The device is used to assist in activities of daily living (ADLs).
    Device Description
    The DEKA Arm System is a lithium-ion battery operated upper limb prosthesis intended to restore limb functions in individuals who lost all (i.e., shoulder disarticulations) or part of either upper limb (e.g., trans-radial amputation). Three configurations may exist, depending on the level of amputation or congenital defect: shoulder configuration (SC), humeral configuration (HC), and radial configuration (RC). It can provide up to 10 active degrees of freedom. Main components consist of Mechanical limb hardware, Arm Control Interfaces (ACI) that record user input signals (myoelectric recording electrodes, discrete bump switches, linear transducers, Inertial Measurement Units (IMUs), and force sensing resistors), Inertial Measurement Units (IMU) that record arm and foot movements, Master Arm Controller (MAC) that is the main processor, Arm Control Modules (ACM)/Hand Control Module (HCM) that control movement and are used for each respective limb component, and One or more battery modules and holsters. These components communicate via the Controller Area Network (CAN). The device is powered through a separate power bus. The system, not including the IMUs, is IP52 rated. The MAC controls wrist movement only, but oversees all actuators. There is afferent and efferent communication between the MAC and ACMs, HCM, IMUs, ACIs and battery module. The ACMs control actuators above the wrist while the HCM controls actuators below the wrist. The battery module may be embedded inside the arm, or worn outside the arm. IMUs do have a Power Control Module for the battery and are IP57 liquid/particle ingress rated. The hand has a grip release button that will release the grip in emergencies. The arm communicates wirelessly via 2 RF channels to a personal computer (PC) for configuration, as well as up to two IMUs. Signal acquisition from the user may be derived from cutaneous myoelectric recording electrodes, discrete bump switches, linear transducers, IMUs, and force sensing resistors, with the ability to accommodate 4 inputs (including up to 2 wireless inputs). Each of the 4 input methods may use up to 4 channels each. Wireless input comes only from the IMUs. Wired input is acquired through the ACIs and transmitted to the MAC. Modes are used to control the 10 degrees of freedom, including Standby, Hand, and Arm modes. Feedback will be provided by a tactor and an LED control display on the arm.
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