BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HES ULTRASONIC THERAPY APPLIANCE

    K Number: K040798 · Decision Aug 4, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    88
    Applicant Total
    2
    Review Days
    128

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    Basic Information

    Device Name
    HES ULTRASONIC THERAPY APPLIANCE
    K Number
    K040798
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5300
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hwang Sun Enterprise Co., Ltd.
    Date Received
    March 29, 2004
    Decision Date
    August 4, 2004
    Product Code
    IMI
    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
    IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

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    Other Clearances by Hwang Sun Enterprise Co., Ltd.

    K Number Device Name
    K050410 HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)