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

    Pain Therapy Device

    K Number: K163611 · Decision Sep 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    12
    Review Days
    271

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    Basic Information

    Device Name
    Pain Therapy Device
    K Number
    K163611
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangzhou Xinbo Electronic Co., Ltd.
    Date Received
    December 22, 2016
    Decision Date
    September 19, 2017
    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 Guangzhou Xinbo Electronic Co., Ltd.

    K Number Device Name
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    K231164 Conductive carbon film electrode
    K202671 DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
    K212948 Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)
    K202636 Metallic Fabric Electrodes
    K202638 Pain Therapy Device
    K200402 DR-HO'S Electro Therapy Conductive Gel
    K190118 Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
    Search all 12 clearances from Guangzhou Xinbo Electronic Co., Ltd. →