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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 K152676
Device Name FD TENS 2090, FD TENS 2095
Applicant
Fuji Dynamics , Ltd.
1-3, 23/F., Laws Commerical Plaza, 788 Cheung Sha Wan Rd.
Hong Kong,  CN
Applicant Contact MAN CHUNG MAN
Correspondent
Fuji Dynamics , Ltd.
1-3, 23/F., Laws Commerical Plaza, 788 Cheung Sha Wan Rd.
Hong Kong,  CN
Correspondent Contact MAN CHUNG MAN
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
IPF  
Date Received09/18/2015
Decision Date 01/22/2016
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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