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510(k) Data Aggregation

    K Number
    K163150
    Device Name
    ViMove2
    Manufacturer
    DORSAVI LTD
    Date Cleared
    2017-07-14

    (247 days)

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

    DORSAVI LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ViMove2 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
    ViMove2 is a wireless electronic device used by healthcare professionals to accurately measure, record and analyze movement and muscle activity of the lower back. The device obiectively measures, records and analyzes angular movement and muscle activity. Under the direction of the healthcare professional, the software quides the patient through a series of dynamic movements and static postures in standing and sitting positions. ViMove2 then measures the range of motion and muscle activity, streams the data live via BTLE to a host device, e.g. PC, tablet or smart phone, and generates a personalized assessment report including comparisons to normative values. ViMove2 is comprised of the following key components: - · 4 Wireless Sensors (2 movement and 2 muscle activity) - · Disposable Application Pads for attaching sensors to the patient. - · ViMove software package
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    K Number
    K142494
    Device Name
    ViMove
    Manufacturer
    dorsaVi Ltd.
    Date Cleared
    2015-05-28

    (265 days)

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

    dorsaVi Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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