BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    FISIOWARM 7.0

    K Number: K232966 · Decision Dec 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    77
    Applicant Total
    1
    Review Days
    462

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    Basic Information

    Device Name
    FISIOWARM 7.0
    K Number
    K232966
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Golden Star Srl
    Date Received
    September 21, 2023
    Decision Date
    December 26, 2024
    Product Code
    PBX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PBX Massager, Vacuum, Radio Frequency Induced Heat

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