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510(k) Data Aggregation

    K Number
    K172882
    Device Name
    UINCARE HOME
    Manufacturer
    UINCARE Corp.
    Date Cleared
    2018-05-10

    (231 days)

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

    UINCARE Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UINCARE software system used with the Microsoft Kinect is intended to be used to support the physical rehabilitation of adults in the clinic or at home. The system includes rehabilitation exercises for the lower and upper extremities with audio- visual feedback & graphic movement representations for patients as well as remotely accessible patient performance metrics for the medical professional. exercise guidance and approval by the medical professional is required prior to use.
    Device Description
    The UINCARE HOME software system used with the RGB-D Camera is intended to be used to support the physical rehabilitation of adults in the clinic or at home. The system includes rehabilitation exercises for the lower and upper extremities 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. The UINCARE HOME software utilizes three off-the-shelf accessories: a motion sensing camera, a monitor and a computer; to provide physical therapists and physicians with a software system to prescribe customized physical therapy plans for patients. UINCARE HOME software provides medical professionals the tools to record and track movements in threedimensional space in order to identify motion and count repetitions during patient participation with a prescribed exercise. Data derived from motion tracking as well as the patient performance metrics can be reviewed by medical professionals to assess exercise movements and adherence to the prescribed exercise. The UINCARE HOME is a software tool that helps extend that expertise. The UINCARE HOME software has three separate applications. - (1) UINCARE Client: Patient Application. This application prompts and monitors patients in the performance of a therapy prescribed by their Clinician, monitors and reports exercise data to the Clinician for analysis, and permits a Patient to communicate with that Clinician. - (2) UINCARE Manager: Clinician Application. This application allows a Clinician to define and update a patient's personal data, a patient's therapy prescription, to monitor a patient's performance of that therapy, and permits a Clinician to communicate with a patient. - (3) UINCARE Server: Cloud-based Server. It provides to communicate between the UINCARE Client and UINCARE Manager by the internet as well as to deliver and store the patient information, exercise program information and the result of exercise performed by the patient.
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