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510(k) Data Aggregation

    K Number
    K133951
    Device Name
    SMARTTOUCH
    Manufacturer
    NEXUS6, LTD.
    Date Cleared
    2014-04-25

    (123 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEXUS6, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartTouch is intended for single-patient use as an electronic data capture accessory for recording actuations of prescribed MDI usage. This may be used in the following applications: - In clinical trials, where researchers need to know when a patient has actuated their trial MDI . medication; - In clinical practice, where specialists, general practitioners, nurses, and educators need to know if . a patient has actuated their prescribed MDI medication. - In self-management, where patients need to track their medication use as part of their . management plan. The SmartTouch is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function.
    Device Description
    SmartTouch is used to provide a compliance monitoring for use of a Metered Dose Inhaler (MDI). SmartTouch is a clip-on device that attaches externally around the enclosure of an MDI. Optical and pressure sensor methods are used to detect MDI presence and actuation, and the device logs the usage history of the MDI. The device includes an LED indicator and control button to check device status and manually initiate communications functions. The SmartTouch has a Bluetooth interface to wirelessly exchange data with a communications device.
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    K Number
    K091803
    Device Name
    SMARTTRACK SYSTEM
    Manufacturer
    NEXUS6, LTD.
    Date Cleared
    2009-10-09

    (115 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEXUS6, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartTrack System is intended for single-patient use as an electronic data capture accessory for recording and monitoring actuations of prescribed MDI usage. This may be used in the following applications: - In clinical trials, where researchers need to know when a patient has actuated their trial MDI medication; - In clinical practice, where specialists, general practitioners, and nurse educators need to know if a patient has actuated their prescribed MDI medication. The SmartTrack is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function.
    Device Description
    The SmartTrack System consists of three modules used to provide a compliance monitoring function for use of a Metered Dose Inhaler (MDI). - SmartTrack is a clip-on module that attaches externally around the enclosure of an MDI, using an optical sensor to detect MDI actuation, to log the usage history of the MDI. The device includes an LCD display and control buttons to review basic data and adjust device settings. Various device status conditions are indicated to the user, and logged to provide potentially relevant context for later review of MDI usage history data. - SmartTrack Docking Station is an optical interface cradle used to download data stored on the SmartTrack module, via USB cable connection to a PC, and allow for interaction by the offline software with device settings and status monitoring. - Respiratory Analyzer is a software application for use on a PC that provides for offline review of the MDI compliance data logged by the SmartTrack module. Data is stored in database files with patient, medication, and prescribed dose information, and is available for review and export in various table and graph formats to highlight MDI usage characteristics.
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