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510(k) Data Aggregation

    K Number
    K213655
    Device Name
    HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)
    Manufacturer
    Date Cleared
    2023-01-17

    (424 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    HillTek LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HiToP®4touch, HiToP®2touch, and HiToP®1touch is intended to be used as Powered muscle stimulator - Relaxation of muscle spasms - Increase local blood circulation - Muscle re-education - Maintaining or increasing range of motion TENS - Symptomatic relief and management of chronic, intractable pain
    Device Description
    The High Tone Power therapy (HiToP®) is a non-invasive electrical muscle stimulator/ powered muscle stimulator and Transcutaneous Electrical Nerve Stimulator (TENS). The device is designed for pain management, muscle strengthening, training, muscle relaxation, and re-education. The device stimulates the underlying muscle groups through electrical impulses transmitted via electrodes applied on the skin. The device can deliver medium frequency sinusoidal electrical waves with different programmable parameters such as frequency, duration of rest, and total session duration to underlying muscle groups. In High Tone power therapy, the amplitude and the frequency are modulated simultaneously. The High Tone Power Therapy devices (HiToP®) provide a therapy with medium frequency sine current waves ranging from 4096 – 32768 Hz. The amplitude (A) and frequency (f) of Sine waves can be simultaneously modulated, so this method is called SimulFAM® which stands for Simultaneous Frequency Amplitude Modulation. SimulFAM®X A frequency scan of three octaves is realized. The frequency scan is realized with different speed (0.1 - 200 Hz). There are three models of HiToP®, which are HiToP® touch, HiToP® 1 touch. Each model's intended use, working principle, product structure, and significant parameters are the slight difference in product appearance and number of programs. HiToP®4 touch, HiToP®2 touch, HiToP®1 touch is used at healthcare facilities and hospitals. The device's parameters are controlled by the driver (control knob), and the user can select the desired therapy using a graphical user interface.
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