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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 K192087
Device Name Combo Electrotherapy Device
Applicant
Shenzhen Roundwhale Technology Co., Ltd.
202, 2/F, Building 27, Dafa Industrial Park
Longxi Community, Longgang Street
Shenzhen,  CN 518108
Applicant Contact Kevin Zhang
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co Ltd
Room 2012#, Gebu commercial building, Hongxing community,
Songgang street
Shenzhen,  CN 518105
Correspondent Contact Reanny Wang
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
GZJ   IPF   NGX  
Date Received08/05/2019
Decision Date 11/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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