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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 K173462
Device Name Wireless Pain Relieve Device Model: LT5018C
Applicant
Shenzhen Dongdixin Technology Co.,Ltd.
No. 3 Building Xilibaimang Xusheng Industrial Estate, Nansha
Shenzhen,  CN 51808
Applicant Contact Siping Yuan
Correspondent
Shenzhen Dongdixin Technology Co.,Ltd.
No. 3 Building Xilibaimang Xusheng Industrial Estate, Nansha
Shenzhen,  CN 51808
Correspondent Contact Siping Yuan
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
NGX   NYN  
Date Received11/08/2017
Decision Date 12/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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