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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 K170145
Device Name Digital TENS Unit
Applicant
Shenzhen Eapply Technology Co., Ltd.
3rd Floor, 2nd Bldg., Hezhou New Industrial Area
Xixiang Town
Shenzhen City,  CN 518000
Applicant Contact LISA HUANG
Correspondent
Shenzhen Eapply Technology Co., Ltd.
3rd Floor, 2nd Bldg., Hezhou New Industrial Area
Xixiang Town
Shenzhen City,  CN 518000
Correspondent Contact LISA HUANG
Regulation Number882.5890
Classification Product Code
NUH  
Date Received01/17/2017
Decision Date 04/29/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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