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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K043407
Device Name INF 4160, MODEL D-FJ27F
Applicant
Fuji Dynamics Limited
Liyatong Industrial District
Lin Chun, Tang Xia
Dong Guan, Guangdong,  CN
Applicant Contact ANTHONY AH YIN SHUM
Correspondent
Fuji Dynamics Limited
Liyatong Industrial District
Lin Chun, Tang Xia
Dong Guan, Guangdong,  CN
Correspondent Contact ANTHONY AH YIN SHUM
Regulation Number882.5890
Classification Product Code
LIH  
Date Received12/10/2004
Decision Date 02/11/2005
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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