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

    iStim S2 OTC Pain Relief TENS

    K Number: K181849 · Decision Aug 10, 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
    iStim S2 OTC Pain Relief TENS
    K Number
    K181849
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Everyway Medical Instruments Co., Ldt.
    Date Received
    July 11, 2018
    Decision Date
    August 10, 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
    K181207 Balego TENS Digital Edition with Accessories for Pain Relief (OTC)