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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 K030355
Device Name COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202
Applicant
Comfort Orthopedic Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Applicant Contact Ke-Min Jen
Correspondent
Comfort Orthopedic Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Correspondent Contact Ke-Min Jen
Regulation Number890.3860
Classification Product Code
ITI  
Date Received02/03/2003
Decision Date 05/20/2003
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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