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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 K162479
Device Name Smart Pain Reliever, Model LT5019
Applicant
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
NO. 3 BUILDING XILIBAIMANG XUSHENG INDUSTRIAL ESTATE
NANSHAN
SHENZHEN,  CN 518108
Applicant Contact TRUMAN SHEN
Correspondent
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
NO. 3 BUILDING XILIBAIMANG XUSHENG INDUSTRIAL ESTATE
NANSHAN
SHENZHEN,  CN 518108
Correspondent Contact TRUMAN SHEN
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
NGX   NYN  
Date Received09/06/2016
Decision Date 02/08/2017
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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