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510(k) Data Aggregation

    K Number
    K221251
    Device Name
    Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
    Manufacturer
    Guangzhou Hua Kai Electronic Technology Co., Ltd.
    Date Cleared
    2022-07-29

    (88 days)

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

    Guangzhou Hua Kai Electronic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PMS (mode 1~3): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (mode 4-6): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. Heating: This function is designed to be used for temporary relief of minor aches and pains.
    Device Description
    Ems Foot Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS), Powered Muscle Stimulator (PMS) and heating qualities. Ems Foot Stimulator has 6 modes (PMS mode 1~3, TENS mode 4~6), which can give certain electrical pulse through 6 pcs of electrode Pad placed on the body to help users to enjoy body stimulation. There are 2 big electrode pads in foot conductive area for feet placed on the main unit to help users to enjoy sole stimulation. And a heating belt can provide heating treatment on waist area. The main unit has the operating elements of Power on/off switch, ON/OFF Switch, Display screen, 2 Mode Selection keys, 2 Intensity Selection keys and a time setting key. The LCD display screen can show selected mode, output intensity of body and sole, heating level and time remaining of an application mode. The remote controller has a ON/OFF Switch to control the EMS/ TENS treatment, a ON/OFF switch to control heating treatment, 2 mode selection keys, 2 intensity selection keys, 2 heating adjust keys and a time setting key. The heating belt and foot conductive pad can only warm the waist and foot rang 30 to 41 degree C The Heating adjust keys on remote controller can help user to adjust the temperature for warming the waist and foot simultaneously. The heating time is same as the treatment time you selected. The heating and stimulation can be applied simultaneously. There are 4 models, model HK701, HK701A, and HK701C, all the four models include a main unit and many accessories. The main unit of the four models are the same, the difference is only the accessories included in the package, so the function is a little different.
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