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

    Cryon-X Cold Compression

    K Number: K253150 · Decision Oct 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    10
    Review Days
    29

    Basic Information

    Device Name
    Cryon-X Cold Compression
    K Number
    K253150
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jkh Health Co., Ltd.
    Date Received
    September 25, 2025
    Decision Date
    October 24, 2025
    Product Code
    IRP
    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
    IRP Massager, Powered Inflatable Tube

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    Other Clearances by Jkh Health Co., Ltd.

    K Number Device Name
    K240788 Ultrasound Stimulator
    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