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

    TENS

    K Number: K133979 · Decision Aug 26, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    1
    Review Days
    243

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    Basic Information

    Device Name
    TENS
    K Number
    K133979
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sunmas (H.K.) Trading Limited
    Date Received
    December 26, 2013
    Decision Date
    August 26, 2014
    Product Code
    NUH
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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