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    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7

    K Number: K071596 · Decision Feb 15, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    21
    Review Days
    248

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    Basic Information

    Device Name
    POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7
    K Number
    K071596
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nihon Seimitsu Sokki Co., Ltd.
    Date Received
    June 12, 2007
    Decision Date
    February 15, 2008
    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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