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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 K120217
Model CT1000
Device Name SONICSTIMU COMBO THERAPEUTIC DEVICE
Original Applicant
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
no. 3 building xilibaimang
xusheng industrial estate
shenzhen,  CH 518108
Original Contact kang jian ping
Regulation Number890.5860
Classification Product Code
IMG  
Subsequent Product Codes
GZJ   LIH  
Date Received01/24/2012
Decision Date 11/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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