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

    Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)

    K Number: K231425 · Decision Mar 27, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    12
    Review Days
    315

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    Basic Information

    Device Name
    Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
    K Number
    K231425
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wuxi Jiajian Medical Instrument Co., Ltd.
    Date Received
    May 17, 2023
    Decision Date
    March 27, 2024
    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 Wuxi Jiajian Medical Instrument Co., Ltd.

    K Number Device Name
    K244030 Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
    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
    K090199 JIAJIAN ACUPUNCTURE NEEDLE
    Search all 12 clearances from Wuxi Jiajian Medical Instrument Co., Ltd. →