Microcurrent Device (Model: HBR2-1)

Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Shenzhen DJ Medical Equipment Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Dj Medical Equipment Co., Ltd. with the FDA for Microcurrent Device (model: Hbr2-1).

Pre-market Notification Details

Device IDK211055
510k NumberK211055
Device Name:Microcurrent Device (Model: HBR2-1)
ClassificationStimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant Shenzhen DJ Medical Equipment Co., Ltd. Room 801, Building A, FirstFlag Science & Technology Park, No. 26 Baili Road, Nanwan Street. Shenzhen,  CN
ContactJet Li
CorrespondentJet Li
Guangzhou KEDA Biology Technology Co Ltd 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou,  CN
Product CodeNFO  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-09
Decision Date2021-11-05

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