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

    Needle Stimulator

    K Number: K202861 · Decision Aug 27, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    22
    Applicant Total
    12
    Review Days
    333

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    Basic Information

    Device Name
    Needle Stimulator
    K Number
    K202861
    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
    September 28, 2020
    Decision Date
    August 27, 2021
    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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    Other Clearances by Wuxi Jiajian Medical Instrument Co., Ltd.

    K Number Device Name
    K244030 Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
    K231425 Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
    K222879 Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
    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. →