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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
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