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510(k) Data Aggregation

    K Number
    K192474
    Device Name
    VERA
    Manufacturer
    Reflexion Health, Inc.
    Date Cleared
    2019-10-10

    (30 days)

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

    Reflexion Health, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the upper extremity, trunk, and lower extremity with audiovisual feedback & graphic movement representations for patients as well as videos of the patients performing the exercises which can be remotely accessed by the clinician. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.
    Device Description
    Not Found
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    K Number
    K182333
    Device Name
    Vera
    Manufacturer
    Reflexion Health, Inc.
    Date Cleared
    2019-04-09

    (224 days)

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

    Reflexion Health, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
    Ask a Question
    K Number
    K150462
    Device Name
    Vera
    Manufacturer
    Reflexion Health, Inc.
    Date Cleared
    2015-10-30

    (249 days)

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

    Reflexion Health, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the lower extremity with audio-visual feedback & graphic movement representations for patients as well as remotely accessible patient performance video. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.
    Device Description
    The Vera™ 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. Vera™ software provides medical professionals the tools to record video and track movements in three-dimensional 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 recorded video can be reviewed by medical professionals to assess exercise movements and adherence to the prescribed exercise; Vera™ is a software tool that helps extend that expertise. The Vera™ software has three separate applications: Patient Application, Clinician Application, and Server Application.
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