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510(k) Data Aggregation

    K Number
    K200558
    Device Name
    Smart Neck Stimulator
    Date Cleared
    2021-10-04

    (580 days)

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

    GUANDONG SKG INTELLIGENT TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Smart Neck Stimulator is designed to temporarily relieve pain associated with sore and aching muscles in the back of neck due to strain from exercise or normal household work activities.
    Device Description
    The subject device is intended to use on back of neck and it designed accord with human body cervical physiological curvature of streamlined ring design. The device totally has 3 modes and each mode has 15 output Intensity Levels, so the device can give certain electrical pulse through the electrode pads on the skin to help users to enjoy back neck stimulation. It can also provide a constant temperature of 37°C to 41°C to provide a warming sensation. The subject device can be controlled by a remote control which based on the radiofrequency technology. There are 5 buttons in the remote control, the "M" button for modes selection, "+" or "-" button for intensity selected to increase or decrease, the " "" button intends to turn the heating function on and the " Ho button intends to turn the heating function off. The device can be turned on when both power button on subject device has been turned on and the treatment mode can be selected by the remote control.
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