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510(k) Data Aggregation

    K Number
    K150995
    Device Name
    Electronic Pulse Stimulator
    Manufacturer
    SHENZHEN JINGKEHUI ELECTRONIC CO., LTD
    Date Cleared
    2015-07-06

    (82 days)

    Product Code
    NUH, NGX
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN JINGKEHUI ELECTRONIC CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
    Device Description
    Not Found
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    K Number
    K141260
    Device Name
    ELECTRONIC PULSE STIMULATOR
    Manufacturer
    SHENZHEN JINGKEHUI ELECTRONIC CO., LTD
    Date Cleared
    2014-09-17

    (125 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN JINGKEHUI ELECTRONIC CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
    Device Description
    The subject device is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-the-counter use to temporarily relieve pain in different body areas. The subject device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse to the user's skin through the electrode pads for pain relief. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.
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    K Number
    K131921
    Device Name
    ELECTRONIC PULSE STIMULATOR
    Manufacturer
    SHENZHEN JINGKEHUI ELECTRONIC CO., LTD
    Date Cleared
    2013-11-15

    (142 days)

    Product Code
    NUH, NGX
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN JINGKEHUI ELECTRONIC CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg, due to strain from exercise or normal household and work activities.
    Device Description
    The Electronic Pulse Stimulator is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-the-counter use to relieve pain in different body areas (waist, back, neck, shoulders, legs, and arms). The proposed Electronic Pulse Stimulator, which is compact, portable, and microprocessorcontrolled, delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin for pain relief. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.
    Ask a Question

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