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

    Ultrasound Stimulator

    K Number: K240788 · Decision Jun 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    88
    Applicant Total
    10
    Review Days
    439

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    Basic Information

    Device Name
    Ultrasound Stimulator
    K Number
    K240788
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5300
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jkh Health Co., Ltd.
    Date Received
    March 22, 2024
    Decision Date
    June 4, 2025
    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 Jkh Health Co., Ltd.

    K Number Device Name
    K253150 Cryon-X Cold Compression
    K240986 Cold Compression
    K240011 Lymphedema Compression
    K223541 Cold/Hot Compression
    K211050 Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
    K202839 Overlapped Compression Therapy
    K200561 StimPlus Patch, StimPlus Patch, StimPlus Patch
    K162517 Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
    K153520 Electronic Pulse Stimulator