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510(k) Data Aggregation

    K Number
    K183674
    Device Name
    Electronic Pulse Stimulator
    Date Cleared
    2019-10-11

    (288 days)

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

    Shenzhen Leading Perfection Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Mode 1 (PMS): To be used for stimulating healthy muscles in order to improve and facilitate muscle performance. Mode 2 (TENS): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities
    Device Description
    Electronic Pulse Stimulator is a product that adopts modern electronic science and technology to delivers electric pulses generated to the user's skin through the electrodes. It has two modes of different pulse frequencies, mode 1 uses Electrical Muscle Stimulation (EMS) technology for muscle training and mode 2 uses Transcutaneous Electrical Nerve Stimulation (TENS) technology to temporary relieve pain. The device includes operating elements of Power ON/OFF button, intensity increase"+" button, and intensity decrease"-" button and Mode selection button, and could be attached and detached to the electrode pad through the snap-on connector. In additional, according to different simulation-needed bodies, users can choose the four types of electrode pad based on their own situation. Electronic Pulse Stimulator is suitable for the simulation-needed bodies including hips, arms and legs, abdomen, and feet.
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