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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
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