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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
510(k) Number K092627
Device Name CT2011 SONICSTIMU PAIN RELIEF DEVICE
Applicant
Shenzhen Dongdixin Technology Co., Ltd.
Xilixiaobaimang
Shenzhen, Guangdong,  CN 518108
Applicant Contact ZHIGNAG ZHAO
Correspondent
Shenzhen Dongdixin Technology Co., Ltd.
Xilixiaobaimang
Shenzhen, Guangdong,  CN 518108
Correspondent Contact ZHIGNAG ZHAO
Regulation Number890.5860
Classification Product Code
IMG  
Subsequent Product Code
GZJ  
Date Received08/26/2009
Decision Date 01/14/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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