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    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇳 China

    Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)

    K Number: K244030 · Decision Mar 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    22
    Applicant Total
    12
    Review Days
    88

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    Basic Information

    Device Name
    Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
    K Number
    K244030
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wuxi Jiajian Medical Instrument Co., Ltd.
    Date Received
    December 30, 2024
    Decision Date
    March 28, 2025
    Product Code
    BWK
    Advisory Committee
    Unknown
    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
    BWK Stimulator, Electro-Acupuncture

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