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

    SM Electrodes

    K Number: K183154 · Decision Mar 26, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    9
    Review Days
    132

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    Basic Information

    Device Name
    SM Electrodes
    K Number
    K183154
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hong Qiangxing (Shenzhen) Electronics Limited
    Date Received
    November 14, 2018
    Decision Date
    March 26, 2019
    Product Code
    GXY
    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
    GXY Electrode, Cutaneous

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    Other Clearances by Hong Qiangxing (Shenzhen) Electronics Limited

    K Number Device Name
    K253740 TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
    K220283 TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
    K220152 TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
    K220150 TENS & PMS (Model: SM9126)
    K201354 TENS & PMS
    K190009 Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
    K133108 FIT BELT
    K121719 SM TENS & PMS