BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Ballancer 505 System, Model 1201-AC

    K Number: K150269 · Decision May 26, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    17
    Review Days
    111

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    Basic Information

    Device Name
    Ballancer 505 System, Model 1201-AC
    K Number
    K150269
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mego Afek AC , Ltd.
    Date Received
    February 4, 2015
    Decision Date
    May 26, 2015
    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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