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510(k) Data Aggregation

    K Number
    K030714
    Device Name
    PEAK MOTUS
    Manufacturer
    PEAK PERFORMANCE TECHNOLOGIES, INC
    Date Cleared
    2003-05-16

    (71 days)

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

    PEAK PERFORMANCE TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Computer and video system used to quantify and graphically display human movement patterns and techniques for uses such as assessment and training of limb or body motion in gait analysis, prosthetic design, pre/post rehabilitation evaluation, physical therapy, and the like.
    Device Description
    The system uses off-the-shelf video cameras, sensors, and computers to collect, quantify, and document human movement in two-dimensional or three-dimensional space. The proprietary elements of the system are Peak's software applications, which run on Microsoft Windows, and an interface box, which can mix and synchronize multiple digital and analog inputs when active data capture is used. The system can effect the capture of real-time video images of motion along with associated sensor information, then sequence the coordinate and sensor information for recording on the computer. Alternatively, the system can use video recordings to provide the motion information. Motion and sensor data are recorded, analyzed, and displayed or reported from the computer. A typical study involves recording the locations of small reflective markers on subjects as movement occurs. This provides instant coordinate data. Coordinate data may also be gathered from digitized video sequences. Analog sensors, such as force platforms or EMG systems, may also be part of the instrumentation during movement. Their information can be synchronized, processed, and displayed along with the coordinate information. The system can calculate standard 2-D or 3-D kinematic and kinetic parameters using specific calculation modules. A report generation package displays and reports the data: in raw or processed form. step-by-step, or sequentially. The Peak Motus system may include software modules, such as - * Advanced video or 3D-optical-motion-capture module - * 2D and/or 3D kinematic calculation and display software - * Analog acquisition module - * 3D pan and tilt module - * KineCalc mathematical analysis module - * Peak Motus Gait Analysis Template Its hardware comprises a Microsoft Windows computer workstation with proprietary synchronizing and processing boards, and a variety of equipment setups, including - * Purchased cameras, VCRs, lights, calibration frames, high-speed video - * Video, optical-capture, and analog-acquisition boards - * Event synchronization unit - Analog EMG and force-platform systems and analog-to-digital interface unit (accepts up to 64 sensors) Movement tracking can be done with or without markers in virtually any collection environment—indoors, outdoors, or even under water. For most medical applications, the tracking is done indoors in a controlled laboratory environment with markers. The Peak Motus System has standard data reduction algorithms for editing, filtering and calculating linear and anqular displacements, velocities, and accelerations. Specialized templates are available for custom calculations: for example, the Peak Motus 3D Gait Analysis Template provides industry-standard gait-analysis calculations such as body segment angles. joint forces, moments, and powers. The systems' report and display package can print standard reports or can display data on the computer screen through a multimedia-display tool. Parametric data created with the system may be displayed as line graphs, x-y plots, bar graphs, stick figures (with vector overlays), text, and data tables.
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