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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pad, heating, powered
510(k) Number K111273
Model EH-6601, 6603, 6604 THRU 6614
Device Name FIR HEAT THERAPHY SYSYEMS
Original Applicant
SHENZHEN ANPAN TECHNOLOGY CO., LTD.
#44, 2nd road, xiakeng, tongle
community, long gang town
shenzhen,  CH 518116
Original Contact wang tao
Regulation Number890.5740
Classification Product Code
IRT  
Subsequent Product Code
ILY  
Date Received05/04/2011
Decision Date 11/08/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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