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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K211055
Device Name Microcurrent device (Model: HBR2-1)
Applicant
Shenzhen DJ Medical Equipment Co., Ltd.
Rm. 801, Bldg. A, Firstflag Science & Technology Park,
# 26 Baili Rd., Nanwan St..
Shenzhen,  CN
Applicant Contact Jet Li
Correspondent
Guangzhou Keda Biology Technology Co, Ltd.
6f, #1 Tiantai Rd., Science City, Luogang District
Gaungzhou,  CN
Correspondent Contact Jet Li
Regulation Number882.5890
Classification Product Code
NFO  
Subsequent Product Code
OHS  
Date Received04/09/2021
Decision Date 11/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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