BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇷 Brazil

    Therapy EC, Therapy XT

    K Number: K232813 · Decision Dec 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    53
    Applicant Total
    1
    Review Days
    463

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    Basic Information

    Device Name
    Therapy EC, Therapy XT
    K Number
    K232813
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dmc Importacao E Exportacao DE Equipamentos Ltda
    Date Received
    September 13, 2023
    Decision Date
    December 19, 2024
    Product Code
    NHN
    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
    NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

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