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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 K033097
Device Name TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02
Applicant
TAIWAN KING STRONG CO., LTD.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY,  TW 300
Applicant Contact JEN KE-MIN
Correspondent
TAIWAN KING STRONG CO., LTD.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY,  TW 300
Correspondent Contact JEN KE-MIN
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/29/2003
Decision Date 11/12/2003
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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