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510(k) Data Aggregation

    K Number
    K162817
    Device Name
    Noddle(TM)
    Date Cleared
    2017-01-18

    (104 days)

    Product Code
    Regulation Number
    890.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    IOWA ADAPTIVE TECHNOLOGIES, INC. DBA VOXELLO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Noddle™ is indicated for use by patients who have physical limitations, weaknesses and/or limited communication abilities in order to assist them with summoning and communicating with their caregiver by controlling other devices such as the nurse call and speech generation devices. To use the noddle™ patients should be sufficiently cognitively intact so that they can produce intentional gestures and intend to communicate with caregivers.
    Device Description
    The Voxello noddle™ is a patient assistive communication device that accepts signals from a sensor to determine when a disabled patient is attempting to intentionally gesture for control of a device or system. The Voxello noddle™ interprets the signals from the sensor to allow the user to control up to three output switches. These outputs may be connected via hardwire or Bluetooth connection to control or access devices such as nurse call stations, and/or speech generation devices.
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