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510(k) Data Aggregation

    K Number
    K143034
    Device Name
    Jintronix
    Manufacturer
    JINTRONIX INC.
    Date Cleared
    2015-04-22

    (182 days)

    Product Code
    LXJ
    Regulation Number
    890.5360
    Why did this record match?
    Applicant Name (Manufacturer) :

    JINTRONIX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Jintronix is a software system used with the Microsoft Kinect v2 intended to be used to support the physical rehabilitation of adults in the clinic/ at home. The system includes rehabilitation exercises for the upper extremity, trunk, and lower extremity with audio-visual feedback & graphic movement representations for patients as well as remotely accessible patient performance metrics for the medical professional. Patient assessment, exercise guidance and approval by the medical professional is required prior to use.
    Device Description
    Jintronix Version 2.0.140905, a software system comprising of a client application and a web application is to be used with the Microsoft Kinect version 2 to support the physical rehabilitation of adults in the clinic/ at home. Through the client application, the patient engages in their rehabilitation exercises. Using the Microsoft Kinect for Windows, which tracks the patient's upper extremity, trunk, and lower body joint positions as they move, the software provides a graphic representation of the patient's movements, as well as activities that include visual and audio feedback to support the patient in performing therapeutic exercise. As the patient engages in exercises, the system records performance metrics, such as the speed and precision of their movements. These metrics are then sent to a remote web application. Clinicians, through a "clinician interface" of the Client application, securely access the remote web application to remotely monitor the progress of their patients, and modify the exercise program through program customizations (for example, difficulty level) based on patients' needs. Patient assessment, exercise guidance and approval by the medical professional is required prior to use. There is no direct contact with the patient since the device is a software product. No energy is delivered to the subject.
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    K Number
    K130847
    Device Name
    JINTRONIX REHABILITATION SYSTEM (JRS)
    Manufacturer
    JINTRONIX INC.
    Date Cleared
    2014-02-28

    (339 days)

    Product Code
    LXJ
    Regulation Number
    890.5360
    Why did this record match?
    Applicant Name (Manufacturer) :

    JINTRONIX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A software system used with the Microsoft Kinect intended to support the physical rehabilitation of adults in the clinic/ at home. The system includes rehabilitation exercises for the upper extremity and trunk with audio-visual feedback & graphic movement representations for patients as well as remotely accessible patient performance metrics for the medical professional. Patient assessment, exercise guidance and approval by the medical professional is required prior to use.
    Device Description
    The device or software comprises of a client application called JRS Wave and a web application or portal called JRS Portal. The JRS is to be used with the Microsoft Kinect motion sensing technology. JRS Wave includes medically recognized gaming exercises for rehabilitation, audio-visual feedback & graphic movement representations for patients. Using the Microsoft Kinect for Windows to track motion, JRS Wave records performance metrics providing them to qualified medical professionals via JRS Portal. Medical professionals can monitor patient performance, assign or modify rehabilitation exercises in JRS Wave for their patients through the JRS Portal allowing for patients to perform their prescribed rehabilitation program even from the comfort of their home.
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