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510(k) Data Aggregation

    K Number
    K182757
    Device Name
    Espire Elbow Pro, Espire Elbow Hybrid
    Date Cleared
    2018-11-29

    (62 days)

    Product Code
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    College Park Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Espire Elbow is to be used exclusively for external prosthetic fittings of the upper limbs. The Espire Elbow processes user's input signals to activate and control elbow movement.
    Device Description
    The Espire Elbow is an advanced upper extremity prosthetic component that when paired with other manufacturers' devices can create a complete upper extremity prosthetic system. Control means of the Espire Elbow include cutaneous electrodes, linear transducers, touchpads and/or switches. The manual control methods (linear transducer, touchpads, and switches) only require that the patient can press/touch the buttons as well as provide a pull type activation. The cutaneous electrodes offer an advanced method of control that uses the patient's muscle signals to govern the movement of the upper extremity prosthetic system. Depending on patient preferences the Espire Elbow comes in two configurations, Pro and Hybrid. The Espire Elbow (Pro) is designed to provide natural flexion and extension through a powered elbow joint which is activated by the input signals from the user. The Espire Elbow (Hybrid) contains an auto-forearm balance mechanism that assists the user with manually moving the elbow into different positions. use the same battery, electronics, inputs, and outputs. At the time of the fitting a certified prosthetist uses the set-up application to program the device with custom criteria specific for each patient's needs. The setup is completed over a secure Bluetooth connection, no patient information is kept within the application. The Espire Elbow is designed to work seamlessly with most major manufacturers' wrist and hand devices. The Espire Elbow provides the control signals and battery power to these terminal devices. The Espire Elbow is suitable for adult patients that are unilateral above elbow upper limb amputees. The device can be administered via prescription by a licensed and certified prosthetist only. For the prosthetist fitting the arm, CPI does not require any specific training related to the technology. The prosthetist will determine the combination of control means to be used with the Espire Elbow. The Espire Elbow is to be used for assistance in daily living; this includes normal daily routine type activities, as well as returning to work. The Espire Elbow is not indicated for use while driving any motorized vehicle or operation of heavy machinery. The device is also not to be used in any extremely warm or cold environments; this is primarily determined by the battery pack requirements. The battery pack must be removed in order to charge the device, using the supplied wall charger. Use in very wet environments, showering or swimming with the device is also outside the system capabilities.
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