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510(k) Data Aggregation

    K Number
    K211055
    Device Name
    Microcurrent device (Model: HBR2-1)
    Date Cleared
    2021-11-05

    (210 days)

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

    Shenzhen DJ Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes.
    Device Description
    The Microcurrent device (Model: HBR2-1) is a hand-held, non-sterile, reusable device designed to achieve the cosmetic effect. The device consist of main unit and wireless charging station with undetachable USB cable. The device is supplied by internal rechargeable lithium battery. It can be recharged by external charger through the charging station. The device design with Micro current output stimulation function. The MCU-controlled microcurrent circuit generates a low-frequency microcurrent which will applied in the facial skin to do facial stimulation. In the microcurrent stimulation mode, there is ten levels of output intensity which would be adjusted by the button in the device. The device is only intended for home use.
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