BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AIR MASSAGE SYSTEM

    K Number: K780710 · Decision May 9, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    1
    Review Days
    12

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    Basic Information

    Device Name
    AIR MASSAGE SYSTEM
    K Number
    K780710
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Theracom C/O Arent, Fox, Kintner, Plotki
    Date Received
    April 27, 1978
    Decision Date
    May 9, 1978
    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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