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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 K022696
Device Name TEH LIN POWERED WHEELCHAIR, MODEL MDG-201
Applicant
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
NO. 58, FU-CHIUN ST.
HSIN CHU CITY,  TW 300
Applicant Contact JEN KE-MIN
Correspondent
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
NO. 58, FU-CHIUN ST.
HSIN CHU CITY,  TW 300
Correspondent Contact JEN KE-MIN
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/13/2002
Decision Date 02/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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