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510(k) Data Aggregation

    K Number
    K241193
    Device Name
    AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
    Manufacturer
    Marzzan Lucas Jorge
    Date Cleared
    2025-01-31

    (277 days)

    Product Code
    JFB
    Regulation Number
    890.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Marzzan Lucas Jorge

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AGILIS is a Multi-function physical therapy tables intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered flexion, and muscle relaxation therapy. Neither device provides heat therapies.
    Device Description
    The AGILIS multifunction physiotherapy table and its line of models (Plus, Pro and Basic) are devices intended to provide patients with powered distraction, powered flexion, and muscle relaxation therapy. Neither device provides heat therapies. The devices of the AGILIS line are made up of different modules articulated with each other, which provide movements and regulations for the manipulations carried out by the professional. The movements are divided according to the type of operation: manual or electric. Manual operation systems: - . Headpiece. - . Extension of feet. - Drops. . - Dorso - lumbar release/breakaway - Lateral Flexion. ● Electrical operating systems: - . Horizontal elevation. - . Flexion of the lower limb sector. - Extension or linear movement of the lower limb sector (distraction/traction).
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