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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
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    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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    K Number
    K952882
    Device Name
    PERSONAL TELEMEDICINE SYSTEM
    Date Cleared
    1996-09-09

    (444 days)

    Product Code
    Regulation Number
    870.1130
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The American TeleCare, Inc. Personal Telemedicine System (PTS) is intended to be used to transmit medical information between a patient at one location, typically in their home, and a medical practitioner at another location, typically a home care nurse at a central nursing station. Information is transmitted over normal residential telephone lines and utilizes two-way video and voice communication. The PTS is typically used in home health care situations as an augment to home care nursing. In essence, the PTS allows a medical practitioner to make a "video-visit" TM to the patient rather than a physical visit. In this "video-visit," the medical practitioner can conduct many of the same diagnostic tests that would be performed in a physical visit.
    Device Description
    The Personal Telemedicine System (PTS) is an assembly of medical products, each of which was previously cleared by the FDA for commercial distribution to patients for their in home use. These products are assembled into a housing which incorporates a videophone and speakerphone and thereby allows a medical practitioner to communicate directly with a patient in a remote location, both verbally and visually, to perform an examination. Use of the PTS begins by either the medical practitioner placing a call to the patient's videophone or the patient pushing the "CALL" button on the PTS unit to notify the medical practitioner to call them. The medical practitioner then determines the patient's status through questions and answers, through visual examination via the videophone, and through use of the medical products. Visual examination is enhanced by the patient placing themselves in relation to the camera portion of the videophone and by use of a specially made magnifying lens placed in front of the camera portion of the videophone. The medical practitioner walks the patient through use of the medical products and the results of each test are presented verbally to the medical practitioner. The medical products in the PTS unit are being used for the same purposes for which they received 510(k) clearance. The unit as a whole, however, has never been submitted to the FDA for clearance.
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