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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 K020639
Device Name TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER
Applicant
Tisport
1426 E. Third Ave.
Kennewick,  WA  99337
Applicant Contact SANDRA GLADSTONE
Correspondent
Tisport
1426 E. Third Ave.
Kennewick,  WA  99337
Correspondent Contact SANDRA GLADSTONE
Regulation Number890.3860
Classification Product Code
ITI  
Date Received02/27/2002
Decision Date 06/20/2002
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
Predetermined Change
Control Plan Authorized		 No
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