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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 K063030
Device Name COMFORT SCOOTER MODEL LY-EW406
Applicant
COMFORT ORTHOPEDIC CO. LTD.
NO.58,FU-CHIUN ST.
HSIN-CHU CITY,  TW 30067
Applicant Contact Ke-Min Jen
Correspondent
COMFORT ORTHOPEDIC CO. LTD.
NO.58,FU-CHIUN ST.
HSIN-CHU CITY,  TW 30067
Correspondent Contact Ke-Min Jen
Regulation Number890.3800
Classification Product Code
INI  
Date Received10/03/2006
Decision Date 12/04/2006
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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