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510(k) Data Aggregation

    K Number
    K190115
    Device Name
    MHD TENS
    Manufacturer
    MingHuangDa Electronic Co., Ltd
    Date Cleared
    2019-06-19

    (146 days)

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

    MingHuangDa Electronic Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transcutaneous Electrical Nerve Stimulation (Program 2, 3, 4, 6, 8, 9): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. Powered Muscle Stimulation (Program 1, 5, 7, 10, 11, 12): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    MHD TENS is portable and DC 3.7V battery powered device, offering both transcutaneous electrical nerve stimulator (TENS) and powered muscle stimulator (PMS) qualities in one device. MHD TENS has 12 operation programs, which can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. The electronic stimulatory module has the operating elements of Switch, LCD Display screen, Screen lock key, Intensity Modification keys, Timing key, Output sockets, and USB port for battery charging. The LCD screen can display treatment remaining time, battery power, selected program, output port, current intensity, selected intensity and lock state. The device is equipped with accessories of electrode pads, electrode cables, a screen stylus, a battery charger and a USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the AC charger and the built-in lithium battery. The screen stylus is used to touch and operate the display screen. All accessories, including the USB cable, electrode pads, electrode cables, and the charger can only be replaced by the electrodes are interchangeable. The application area of electrode pads must be larger than 12cm². The electrode pads are provided by Shenzhen Mailuokang Technology Co., Ltd. with 510(k) cleared Number K152815.
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