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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 K133929
Device Name HEALTH EXPERT ELCTRONIC STIMULATOR
Applicant
SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED
N0. 43 LONGFENG ROAD
XINSHENG COMMUNITY, LONGGANG STREET, LONGGANG DISTRICT
SHENZHEN CITY, GUANGDONG PROVINCE,  CN 518116
Applicant Contact LI YANG
Correspondent
SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED
N0. 43 LONGFENG ROAD
XINSHENG COMMUNITY, LONGGANG STREET, LONGGANG DISTRICT
SHENZHEN CITY, GUANGDONG PROVINCE,  CN 518116
Correspondent Contact LI YANG
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received12/23/2013
Decision Date 11/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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