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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 K143430
Device Name SmartTENS
Applicant
EASYMED INSTRUMENT CO., LTD.
5/F-6/F, BLOCK A, GUPO GONGMAO BLDG
FENGXIN ROAD, FENGXIANG INDUSTRIAL DISTRICT
DALIANG, SHUNDE, FOSHAN, GUANG DONG,  CN 528300
Applicant Contact Jeffery Wu(Tingjie Wu)
Correspondent
EASYMED INSTRUMENT CO., LTD.
5/F-6/F, BLOCK A, GUPO GONGMAO BLDG
FENGXIN ROAD, FENGXIANG INDUSTRIAL DISTRICT
DALIANG, SHUNDE, FOSHAN, GUANG DONG,  CN 528300
Correspondent Contact Jeffery Wu(Tingjie Wu)
Regulation Number882.5890
Classification Product Code
NUH  
Date Received12/01/2014
Decision Date 05/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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