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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 K244004
Device Name Microcurrent Facial Device (CEC101, EE0101, EEI101)
Applicant
Shenzhen Dachi Communication Co., Ltd.
Rm. 201, 202, 203, Bldg. 3, Phase I, Huangtian Yangbei
Industrial Zone, Huangtian Community, Hangcheng St.
Shenzhen,  CN 518101
Applicant Contact Chunhua Xiao
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Jilan Luo
Regulation Number882.5890
Classification Product Code
NFO  
Date Received12/26/2024
Decision Date 07/10/2025
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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