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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K133108
Device Name FIT BELT
Applicant
HONG QIANG XING (SHENZHEN) ELECTRONICS LIMITED
4F.,JINGCHENG BUILDING, XICHENG INDUSTRIAL ZONE
XIXIANG ROAD, BOA'AN DISTRICT
SHENZHEN,  CN 518102
Applicant Contact XU JIAN HUA
Correspondent
HONG QIANG XING (SHENZHEN) ELECTRONICS LIMITED
4F.,JINGCHENG BUILDING, XICHENG INDUSTRIAL ZONE
XIXIANG ROAD, BOA'AN DISTRICT
SHENZHEN,  CN 518102
Correspondent Contact XU JIAN HUA
Regulation Number890.5850
Classification Product Code
NGX  
Date Received09/30/2013
Decision Date 08/05/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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