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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 K213788
Device Name TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
Applicant
Dongguan Bohuikang Technology Co.,Ltd
5th Floor,No 5, Second St.,Huaide Shui Xiang New Strict,
Humen Town
Dongguan,  CN 523165
Applicant Contact Rihua Meng
Correspondent
Guangdong Jianda Medical Technology Co., Ltd.
906 Rm., Longxiang Garden,
Tianhe District
Guangzhou,  CN 510000
Correspondent Contact Jett Lee
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
IPF   NGX  
Date Received12/06/2021
Decision Date 05/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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