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510(k) Data Aggregation

    K Number
    K233461
    Device Name
    Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
    Manufacturer
    Hi-Dow International, Inc.
    Date Cleared
    2024-01-19

    (88 days)

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

    Hi-Dow International, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS: To be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS: Intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    Not Found
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    K Number
    K163393
    Device Name
    Hi-Dow Wireless TENS/EMS System (Model HD-SN)
    Manufacturer
    Hi-Dow International, Inc.
    Date Cleared
    2017-08-04

    (245 days)

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

    Hi-Dow International, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS: To be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS: It is intended for muscle conditioning, used for stimulating abdomen muscles in order to improve or facilitate muscle performance.
    Device Description
    The Hi-Dow Wireless TENS/EMS System is a battery operated wireless pulse generator that uses radiofrequency signals sent from a wireless remote control unit to wireless receivers attached to the electrodes(s), which are attached to the skin at the area to be treated. The wireless remote controls the intensity and mode functions of the receiver. When used in TENS Modes, the electrical impulses generated by the receivers stimulate the nerves that are causing pain resulting in gentle electrical sensations instead of pain. When used in EMS modes, the electrical impulses generated by the receivers produce muscle contractions, these contractions help to condition and improve the muscles. The Hi-Dow Wireless TENS/EMS System is a double-channel and 4 modes muscle stimulation system that helps to relieve minor muscular aches and pains. The output of both channels can be adjusted individually for intensity in 20 levels and the treatment time is 45 minutes. The device is powered by rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied with the device. The Device consists of an electronic stimulatory module which generates the required stimulation signals, 3 sets of electrode pads and a plug-in charging unit. The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydro gel, no securing materials are required to secure the device to the patient's skin. The electrodes snap onto the receiver.
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