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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
Device Name FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
Applicant
Famidoc Technology Co., Ltd.
East 2/F,Zhixiang Bldg.,71
Block Baoan District
Shenzhen,  CN 518101
Applicant Contact CAO LIANG
Correspondent
Famidoc Technology Co., Ltd.
East 2/F,Zhixiang Bldg.,71
Block Baoan District
Shenzhen,  CN 518101
Correspondent 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 (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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