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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K020684
Device Name FINESUN EMS STIMULATOR
Applicant
Finesun Worldwide Intl. Co., Ltd.
3f, #31, Hu-Pin Rd. #1
Science Based Industrial Park
Hsin-Chu,  TW 300
Applicant Contact CHI-CHU WU CHEN
Correspondent
Finesun Worldwide Intl. Co., Ltd.
3f, #31, Hu-Pin Rd. #1
Science Based Industrial Park
Hsin-Chu,  TW 300
Correspondent Contact CHI-CHU WU CHEN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received03/04/2002
Decision Date 05/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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