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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 K143268
Device Name TENS AND POWERED MUSCLE STIMULATOR
Applicant
SHENZHEN AS-TEC TECHNOLOGY CO., LTD
2C XINGBAOYI INDUSTRIAL BLD., HOUTING VILLAGE, BEITING RD.,
SHAJING
SHENZHEN,  CN 518104
Applicant Contact CONNIE LI
Correspondent
SHANGHAI CV TECHNOLOGY CO., LTD
ROOM 1706 YUESHA BUILDING, NO.128 SONGLE RD., SONGJIANG AREA
SHANGHAI,  CN 201600
Correspondent Contact DORIS DONG
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received11/13/2014
Decision Date 07/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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