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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K202866
Device Name TENS & EMS Device
Applicant
SHenzhen Jianfeng Electronic Technology Co., Ltd.
#902,903 Jialingyu Industry Building, Dapu Road, Houting,
Shajing Town
Baoan District, Shenzhen City,  CN 518104
Applicant Contact Feng Wen
Correspondent
Intertek Testing Services Shenzhen Ltd. Guangzhou.
Block E, No.7-2 Guangdong Software Science Park, Caipin Road
Guangzhou Science City, GETDD,  CN 510700
Correspondent Contact Iris Lin
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received09/28/2020
Decision Date 05/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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