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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 K011846
Device Name BIOTECH POWERED WHEELCHAIR, C650PW
Applicant
Roc Chinese-European Industrial Research Society
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Applicant Contact JEN KE-MIN
Correspondent
Roc Chinese-European Industrial Research Society
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Correspondent Contact JEN KE-MIN
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/12/2001
Decision Date 01/18/2002
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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