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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 K150436
Device Name ComboRehab
Applicant
Shenzhen Dongdixin Technology Co., Ltd.
# 3 Bldg., Xilibaimang Xusheng Industrial Estate
Nanshan
Shenzhen,  CN 518108
Applicant Contact Jianping Kang
Correspondent
Shenzhen Dongdixin Technology Co., Ltd.
# 3 Bldg., Xilibaimang Xusheng Industrial Estate
Nanshan
Shenzhen,  CN 518108
Correspondent Contact Jianping Kang
Regulation Number890.5860
Classification Product Code
IMG  
Subsequent Product Codes
GZI   GZJ   HCC   IPF   LIH  
Date Received02/19/2015
Decision Date 11/13/2015
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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