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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K033032
Device Name WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR
Applicant
Wu'S Tech Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW ROC 300
Applicant Contact Ke-Min Jen
Correspondent
Wu'S Tech Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW ROC 300
Correspondent Contact Ke-Min Jen
Regulation Number890.3800
Classification Product Code
INI  
Date Received09/26/2003
Decision Date 11/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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