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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 K072311
Device Name TILITE AERO X
Applicant
Tisport, LLC
1426 E. Third Ave.
Kennewick,  WA  99337 -9669
Applicant Contact RICHARD S FORMAN
Correspondent
Tisport, LLC
1426 E. Third Ave.
Kennewick,  WA  99337 -9669
Correspondent Contact RICHARD S FORMAN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received08/17/2007
Decision Date 09/21/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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