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

    Electronic Pulse Stimulator

    K Number: K153520 · Decision May 5, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    10
    Review Days
    149

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    Basic Information

    Device Name
    Electronic Pulse Stimulator
    K Number
    K153520
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jkh Health Co., Ltd.
    Date Received
    December 8, 2015
    Decision Date
    May 5, 2016
    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 Jkh Health Co., Ltd.

    K Number Device Name
    K253150 Cryon-X Cold Compression
    K240788 Ultrasound Stimulator
    K240986 Cold Compression
    K240011 Lymphedema Compression
    K223541 Cold/Hot Compression
    K211050 Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
    K202839 Overlapped Compression Therapy
    K200561 StimPlus Patch, StimPlus Patch, StimPlus Patch
    K162517 Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13