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

    Hot and Cold Compression System (A02-C-032)

    K Number: K252386 · Decision Apr 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    4
    Review Days
    246

    Basic Information

    Device Name
    Hot and Cold Compression System (A02-C-032)
    K Number
    K252386
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chengdu Cryo-Push Medical Technology Co.,Ltd
    Date Received
    July 31, 2025
    Decision Date
    April 3, 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 Chengdu Cryo-Push Medical Technology Co.,Ltd

    K Number Device Name
    K253076 Cryopush Cold Compression Device (A02-P-001)
    K230524 Cold Compression Wrap Pro
    K222669 Cryopush Cold Compression Device