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

    Air Pressure Therapy System

    K Number: K243791 · Decision Jan 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    91
    Registration Numbers
    91
    Same Product Code
    138
    Applicant Total
    2
    Review Days
    34

    Basic Information

    Device Name
    Air Pressure Therapy System
    K Number
    K243791
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Xiamen WeiYou Intelligent Technology Co.,Ltd.
    Date Received
    December 10, 2024
    Decision Date
    January 13, 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 Xiamen WeiYou Intelligent Technology Co.,Ltd.

    K Number Device Name
    K243320 Air Pressure Therapy System (VU-IPC04B)