BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    IF-727 INTERFERENTIAL STIMULATOR

    K Number: K974585 · Decision Mar 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    72
    Applicant Total
    20
    Review Days
    88

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    Basic Information

    Device Name
    IF-727 INTERFERENTIAL STIMULATOR
    K Number
    K974585
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Skylark Device Co., Ltd.
    Date Received
    December 8, 1997
    Decision Date
    March 6, 1998
    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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