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

    TENS device-HeadaTerm 2 (Model: YF-HT2)

    K Number: K230782 · Decision Feb 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    17
    Applicant Total
    2
    Review Days
    341

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    Basic Information

    Device Name
    TENS device-HeadaTerm 2 (Model: YF-HT2)
    K Number
    K230782
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5891
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wat Medical Technology, Inc.
    Date Received
    March 22, 2023
    Decision Date
    February 26, 2024
    Product Code
    PCC
    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
    PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

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    Other Clearances by Wat Medical Technology, Inc.

    K Number Device Name
    K220503 TENS device-EmeTerm 2, Model: YF-ZTY-E2