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510(k) Data Aggregation

    K Number
    K151446
    Device Name
    Recovr Rehabilitation System
    Manufacturer
    Recovr,Inc
    Date Cleared
    2015-09-18

    (112 days)

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

    Recovr,Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Recovr Rehabilitation System is software for use with the Microsoft Kinect motion tracking system that is indicated to support physical rehabilitation of adults in the clinic and at home via performance of therapist-assigned reach exercises for the upper extremities. Patient assessment, exercise guidance, and approval by the medical professional are required prior to use.
    Device Description
    The Recovr Rehabilitation System (RRS) is a software system that presents games to facilitate the completion of therapist designed and prescribed upper extremity repetitive reaching exercises and that collects data for the therapist on the user's game play. The system was designed in collaboration with an experienced neurorehabilitation occupational therapist and rehabilitation research team. The RRS is intended for use in the clinic or at home. Patient assessment, exercise guidance, and approval by the medical professional are required prior to use. The system consists of software, a computer, a primary display monitor, a secondary monitor, and a Microsoft Kinect motion-tracking sensor. Users sit on a bench or stand 6-8 feet away from the primary display monitor. The Kinect sensor is placed along the top or bottom edge of the primary display monitor, and the therapist controls the system from a secondary monitor, mouse, and keyboard off to the side of the primary display monitor. The games are based on a traditional carnival shooting gallery, with targets that pop–up to present reaching tasks. The virtual reality environment incorporates video game principles to engage and motivate users to perform the amount of rehabilitation assigned by the rehabilitation therapist. The system collects data on participant movement and actions throughout each session that allows therapists to track participant performance and improvement across therapy sessions. The device is not supplied sterile or intended to be sterilized by the operator prior to use, and is not intended for single use.
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