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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 K180956
Device Name Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator
Applicant
Shenzhen Roundwhale Technology Co., Ltd.
No. 615, Building C of Sanlian Industrial Zone, Shiyan
Baoan District
Shenzhen,  CN 518108
Applicant Contact Kevin Zhang
Correspondent
Shenzhen Roundwhale Technology Co., Ltd.
No. 615, Building C of Sanlian Industrial Zone, Shiyan
Baoan District
Shenzhen,  CN 518108
Correspondent Contact Kevin Zhang
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received04/12/2018
Decision Date 06/07/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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