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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K111645
Device Name FD TENS 2050 OR SLIDE TENS MODEL FD2050
Applicant
Fuji Dynamics , Ltd.
Unit 1-3, 23/F Laws Commerical
Plaza 788 Cheung Sha Wan Rd.
Hong Kong,  CN CH
Applicant Contact CHING KONG (FELIX) LEE
Correspondent
Fuji Dynamics , Ltd.
Unit 1-3, 23/F Laws Commerical
Plaza 788 Cheung Sha Wan Rd.
Hong Kong,  CN CH
Correspondent Contact CHING KONG (FELIX) LEE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/13/2011
Decision Date 11/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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