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510(k) Data Aggregation
K Number
K211055Device Name
Microcurrent device (Model: HBR2-1)
Manufacturer
Date Cleared
2021-11-05
(210 days)
Product Code
Regulation Number
882.5890Why 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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