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

    JIAJIAN TENS

    K Number: K112288 · Decision May 2, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    12
    Review Days
    267

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    JIAJIAN TENS
    K Number
    K112288
    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
    August 9, 2011
    Decision Date
    May 2, 2012
    Product Code
    GZJ
    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
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GZJ), ordered by most recent decision date.

    STIMPOD NMS460 Nerve Stimulator

    FDA 510(k)
    FDA Class 2 ·Neurology

    actiTENS mini

    FDA 510(k)
    FDA Class 2 ·Neurology

    CP Relief Wand Rx - TENS/NMES

    FDA 510(k)
    FDA Class 2 ·Neurology

    Unipro (K-UNIPRO-US)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENSWave

    FDA 510(k)
    FDA Class 2 ·Neurology

    Electrical Neuromuscular Stimulator, Cure Trio

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    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)
    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
    K090199 JIAJIAN ACUPUNCTURE NEEDLE
    Search all 12 clearances from Wuxi Jiajian Medical Instrument Co., Ltd. →