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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 K011701
Device Name BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR
Applicant
Taiwan Armada Enterprise Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Applicant Contact JEN KE-MIN
Correspondent
Taiwan Armada Enterprise Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Correspondent Contact JEN KE-MIN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received06/01/2001
Decision Date 06/22/2001
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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