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510(k) Data Aggregation

    K Number
    K050410
    Device Name
    HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)
    Manufacturer
    HWANG SUN ENTERPRISE CO., LTD.
    Date Cleared
    2005-07-14

    (147 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    K102524
    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

    The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets specific criteria. The document is a 510(k) clearance letter from the FDA for the HES® Ultrasonic Therapy Appliance, confirming its substantial equivalence to a legally marketed device for the stated indications for use.

    The text does not include:

    • A table of acceptance criteria or reported device performance.
    • Details about sample sizes, data provenance, or ground truth establishment for any studies.
    • Information on expert review, adjudication methods, or MRMC studies.
    • Details about standalone algorithm performance or training sets.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input.

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