BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    DX6605E-TENS, DX6605E-G, DX6609-G

    K Number: K082057 · Decision Feb 26, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    25
    Review Days
    220

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    Basic Information

    Device Name
    DX6605E-TENS, DX6605E-G, DX6609-G
    K Number
    K082057
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Dongdixin Technology Co., Ltd.
    Date Received
    July 21, 2008
    Decision Date
    February 26, 2009
    Product Code
    GZJ
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

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