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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 K023581
Device Name COMFORT AGILE SCOOTER, LY-EW303
Applicant
Comfort Orthopedic Co., Ltd.
No 58, Fu-Chiun St.
Hsin-Chu City,,  TW
Applicant Contact JEN KE-MIN
Correspondent
Comfort Orthopedic Co., Ltd.
No 58, Fu-Chiun St.
Hsin-Chu City,,  TW
Correspondent Contact JEN KE-MIN
Regulation Number890.3800
Classification Product Code
INI  
Date Received10/24/2002
Decision Date 12/02/2002
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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