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

    Balego TENS Digital Edition with Accessories for Pain Relief (OTC)

    K Number: K181207 · Decision Jun 6, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    2
    Review Days
    30

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    Basic Information

    Device Name
    Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
    K Number
    K181207
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Everyway Medical Instruments Co., Ldt.
    Date Received
    May 7, 2018
    Decision Date
    June 6, 2018
    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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    Other Clearances by Everyway Medical Instruments Co., Ldt.

    K Number Device Name
    K181849 iStim S2 OTC Pain Relief TENS