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

    Cryo-Thermo Compression Device (FGK002)

    K Number: K222136 · Decision Mar 8, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    1
    Review Days
    232

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    Basic Information

    Device Name
    Cryo-Thermo Compression Device (FGK002)
    K Number
    K222136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suzhou Microport Rehabtech (Group) Co., Ltd.
    Date Received
    July 19, 2022
    Decision Date
    March 8, 2023
    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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