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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K020188
Device Name BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR
Applicant
Taiwan Armada Enterprise Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Applicant Contact Ke-Min Jen
Correspondent
Taiwan Armada Enterprise Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Correspondent Contact Ke-Min Jen
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/18/2002
Decision Date 03/08/2002
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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