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

    Lymphedema Compression

    K Number: K240011 · Decision Feb 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    10
    Review Days
    52

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    Basic Information

    Device Name
    Lymphedema Compression
    K Number
    K240011
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jkh Health Co., Ltd.
    Date Received
    January 2, 2024
    Decision Date
    February 23, 2024
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOW Sleeve, Limb, Compressible

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    Other Clearances by Jkh Health Co., Ltd.

    K Number Device Name
    K253150 Cryon-X Cold Compression
    K240788 Ultrasound Stimulator
    K240986 Cold 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