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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K050011
Device Name WU'S POWERED WHEELCHAIR, MAMBO F 120
Applicant
Wu'S Tech Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW ROC 300
Applicant Contact JEN KE-MIN
Correspondent
Wu'S Tech Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW ROC 300
Correspondent Contact JEN KE-MIN
Regulation Number890.3860
Classification Product Code
ITI  
Date Received01/03/2005
Decision Date 02/11/2005
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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