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

    JIAJIAN ACUPUNCTURE NEEDLE

    K Number: K090199 · Decision Aug 11, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    90
    Applicant Total
    12
    Review Days
    196

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    Basic Information

    Device Name
    JIAJIAN ACUPUNCTURE NEEDLE
    K Number
    K090199
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5580
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wuxi Jiajian Medical Instrument Co., Ltd.
    Date Received
    January 27, 2009
    Decision Date
    August 11, 2009
    Product Code
    MQX
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQX Needle, Acupuncture, Single Use

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    Other Clearances by Wuxi Jiajian Medical Instrument Co., Ltd.

    K Number Device Name
    K244030 Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
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    K222879 Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
    K202861 Needle Stimulator
    K202893 Transcutaneous Electrical Nerve Stimulator
    K192568 Jiajian Self-Adhesive Electrode
    K123958 JIAJIAN POINTOSELECT DIGITAL
    K130768 JIAJIAN CMN STIMULATOR
    K122812 JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS
    K112288 JIAJIAN TENS
    Search all 12 clearances from Wuxi Jiajian Medical Instrument Co., Ltd. →