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510(k) Data Aggregation

    K Number
    K244041

    Validate with FDA (Live)

    Device Name
    Ultrasound Therapy Workstation (XMS-UET2)
    Manufacturer
    Xemis Medical Technology (Shenzhen) Co., Ltd.
    Date Cleared
    2025-10-07

    (281 days)

    Product Code
    IMG,GZI,GZJ,IPF,LIH
    Regulation Number
    890.5860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K150436
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended for use only in adult patients.

    Therapeutic Ultrasound
    Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

    1. Pain relief, muscle spasms and joint contractures.
    2. Relief of pain, muscle spasms and joint contractures that may be associated with:
      • Adhesive capsulitis
      • Bursitis with slight calcification
      • Myositis
      • Soft tissue injuries
      • Shortened tendons due to past injuries and scar tissues
    3. Relief of sub-chronic, chronic pain and joint contractures resulting from:
      • Capsular tightness
      • Capsular scarring

    For TENS, Interferential, premodulated (IFC), NMS and Microcurrent:

    1. Symptomatic relief of chronic intractable pain
    2. Post-traumatic acute pain
    3. Post-surgical acute pain

    Additionally for NMS, NMS Burst, Hi-Volt and Russian:

    1. Relaxation of Muscle spasms
    2. Prevention or retardation of disuse atrophy
    3. Increasing local blood circulation
    4. Muscle re-education
    5. Maintaining or increasing range of motion
    6. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

    For DC Continuous Mode

    1. Relaxation of muscle spasm
    Device Description

    The Ultrasound Therapy Workstation (model: XMS-UET2) is an AC-powered device designed to use electrical stimulation and therapeutic ultrasound. Key features include ultrasound output and electrical stimulation output. This device is intended for use in healthcare environments such as hospitals, rehabilitation centers, community health service centers, and clinics.
    The device has a color touchscreen display and a control knob with light ring. The screen display shows system information to the user. Both display screen and control knob can assist the user in selecting or adjusting parameters. All controls and indicators are controlled by software.
    Three non-invasive therapeutic methods are available: electrotherapy, ultrasound therapy and combination therapy (ultrasound plus electrical stimulation). For each method, the device is configured with protocols and manual operation, which can facilitate users to choose pre-set protocols or adjust parameters to suit individual needs.

    AI/ML Overview

    N/A

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