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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
510(k) Number K113010
Model FDES100(ED400), FDES101(ED401), FDES102(ED402). FDES103(ED403)
Device Name FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
Original Applicant
FAMIDOC TECHNOLOGY CO., LTD
east 2/f,zhixiang building,71
block baoan district
shenzhen,  CH 518101
Original Contact cao liang
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
GZJ  
Date Received10/11/2011
Decision Date 12/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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