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

    Pressure Therapy System PT1003

    K Number: K181409 · Decision Feb 19, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    3
    Review Days
    265

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    Basic Information

    Device Name
    Pressure Therapy System PT1003
    K Number
    K181409
    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 Senyang Co., Ltd.
    Date Received
    May 30, 2018
    Decision Date
    February 19, 2019
    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 Senyang Co., Ltd.

    K Number Device Name
    K192358 Pressure Therapy System PT1003
    K161907 Pressure Therapy System