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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 K140168
Device Name EASYSTIM TN28_OTC
Applicant
Easymed Instruments Co., Ltd.
5/F-6/F, Block A, Gupo Gongmao Bldg
Fengxin Rd., Fengxiang Industrial District
Daliang, Shunde, Foshan, Guang Dong,  CN 528300
Applicant Contact JEFFERY WU
Correspondent
Easymed Instruments Co., Ltd.
5/F-6/F, Block A, Gupo Gongmao Bldg
Fengxin Rd., Fengxiang Industrial District
Daliang, Shunde, Foshan, Guang Dong,  CN 528300
Correspondent Contact JEFFERY WU
Regulation Number882.5890
Classification Product Code
NUH  
Date Received01/23/2014
Decision Date 08/28/2014
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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