BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇷 Argentina

    AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)

    K Number: K241193 · Decision Jan 31, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    65
    Applicant Total
    1
    Review Days
    277

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    Basic Information

    Device Name
    AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
    K Number
    K241193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5880
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Marzzan Lucas Jorge
    Date Received
    April 29, 2024
    Decision Date
    January 31, 2025
    Product Code
    JFB
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JFB Table, Physical Therapy, Multi Function

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