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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.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY,  TW
Applicant Contact Ke-Min Jen
Correspondent
TAIWAN ARMADA ENTERPRISE CO., LTD.
NO. 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
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