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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 K180331
Device Name Wireless Pain Relieve Device
Applicant
Shenzhen Dongdixin Technology Co., Ltd.
# 3 Bldg. Xilibaimang Xusheng Industrial Estate, Nansha
Shenzhen,  CN 518108
Applicant Contact Siping Yuan
Correspondent
Shenzhen Dongdixin Technology Co., Ltd.
# 3 Bldg. Xilibaimang Xusheng Industrial Estate, Nansha
Shenzhen,  CN 518108
Correspondent Contact Siping Yuan
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NYN  
Date Received02/06/2018
Decision Date 06/22/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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