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510(k) Data Aggregation

    K Number
    K173931
    Device Name
    MindMotion(TM) GO
    Manufacturer
    MindMaze SA
    Date Cleared
    2018-05-17

    (142 days)

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

    MindMaze SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MindMotion™ GO is a medical device software used in combination with the Microsoft Kinect v2 and Leap Motion controller that supports the physical rehabilitation of adults in the clinic and at home. The software includes rehabilitation exercises for the upper extremity, trunk, and lower extremity; audio-visual feedback and graphic movement representations for patients; and patient performance metrics for the medical professional. Patient exercise guidance, and approval by the medical professional is required prior to use.
    Device Description
    Not Found
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    K Number
    K162748
    Device Name
    MindMotionPRO
    Manufacturer
    MindMaze SA
    Date Cleared
    2017-04-24

    (206 days)

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

    MindMaze SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MindMotionPRO is a 3D imaging and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of 3D virtual environments and avatars for visual feedback. These rehabilitation exercises are intended to be conducted in a clinical environment and supervised by a medical professional trained in the proper utilization of the MindMotionPRO.
    Device Description
    MindMotionPRO is a 3D imaging and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of 3D virtual environments and avatars for visual feedback.
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