BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Ultrasound Therapy Workstation (XMS-UET2)

    K Number: K244041 · Decision Oct 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    54
    Applicant Total
    2
    Review Days
    281

    Basic Information

    Device Name
    Ultrasound Therapy Workstation (XMS-UET2)
    K Number
    K244041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xemis Medical Technology (Shenzhen) Co., Ltd.
    Date Received
    December 30, 2024
    Decision Date
    October 7, 2025
    Product Code
    IMG
    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
    IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

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