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510(k) Data Aggregation

    K Number
    K131094
    Device Name
    VIMOVE
    Manufacturer
    DORSA VI PTY. LTD
    Date Cleared
    2014-07-11

    (449 days)

    Product Code
    IKN, HCC, KQX
    Regulation Number
    890.1375
    Why did this record match?
    Applicant Name (Manufacturer) :

    DORSA VI PTY. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ViMove is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.
    Device Description
    ViMove is comprised of five key components: - 4 Wireless Sensors (2 for movement and 2 for muscle activity) - Disposable Application Pads for holding the wireless sensors. movement (DAP-M) and muscle (DAP-E) sensors - Recording and Feedback Device (RFD) is worn in the patient's pocket or within one meter of the sensors - Recharging Cradle - ViMove software package
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