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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 K213741
Device Name TENS & EMS DEVICE (Model: FM-B2403A)
Applicant
Shenzhen Jianfeng Electronic Technology Co. Ltd.
902,903 Jialingyu Industrial Building, Da Pu Road,
Houting Village, Shajing Town, Baoan District
Shenzhen,  CN 518104
Applicant Contact Feng Wen
Correspondent
Shenzhen Jianfeng Electronic Technology Co. Ltd.
902,903 Jialingyu Industrial Building, Da Pu Road,
Houting Village, Shajing Town, Baoan District
Shenzhen,  CN 518104
Correspondent Contact Feng Wen
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received11/29/2021
Decision Date 03/08/2022
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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