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

    ETD4000

    K Number: K202725 · Decision Mar 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    72
    Applicant Total
    2
    Review Days
    190

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    Basic Information

    Device Name
    ETD4000
    K Number
    K202725
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Therasigma, LLC
    Date Received
    September 17, 2020
    Decision Date
    March 26, 2021
    Product Code
    LIH
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LIH Interferential Current Therapy

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