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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
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