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510(k) Data Aggregation

    K Number
    K040798
    Device Name
    HES ULTRASONIC THERAPY APPLIANCE
    Manufacturer
    HWANG SUN ENTERPRISE CO., LTD.
    Date Cleared
    2004-08-04

    (128 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K040776
    Why did this record match?
    Reference Devices :

    K040776

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues for the treatment of selected medical conditions such as temporary relief of minor pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the text provided, I cannot answer your request. The document is a 510(k) clearance letter for an ultrasonic therapy appliance and primarily focuses on regulatory approval. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

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