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

    Cryo And Thermo Therapy System

    K Number: K253919 · Decision Jun 10, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    7
    Review Days
    184

    Basic Information

    Device Name
    Cryo And Thermo Therapy System
    K Number
    K253919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xiamen Weiyou Intelligent Technology Co., Ltd.
    Date Received
    December 8, 2025
    Decision Date
    June 10, 2026
    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 Xiamen Weiyou Intelligent Technology Co., Ltd.

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    K243791 Air Pressure Therapy System
    K243320 Air Pressure Therapy System (VU-IPC04B)
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