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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, for muscle conditioning
510(k) Number K130723
Device Name FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL
Applicant
FAMIDOC TECHNOLOGY CO., LTD
No.212 Yilong Road, Hexi Industrial Zone, Jinxia,
Changan Town
Dongguan,  CN 523853
Applicant Contact REANNY WANG
Correspondent
FAMIDOC TECHNOLOGY CO., LTD
No.212 Yilong Road, Hexi Industrial Zone, Jinxia,
Changan Town
Dongguan,  CN 523853
Correspondent Contact REANNY WANG
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
NUH  
Date Received03/18/2013
Decision Date 02/07/2014
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
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