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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 K033370
Device Name POWERED WHEELCHAIR, MODEL FR168W
Applicant
Freerider Corp
3636 E Columbine Dr.
Phoenix,  AZ  85032
Applicant Contact ROBERT S MCQUATE
Correspondent
Freerider Corp
3636 E Columbine Dr.
Phoenix,  AZ  85032
Correspondent Contact ROBERT S MCQUATE
Regulation Number890.3860
Classification Product Code
ITI  
Date Received10/21/2003
Decision Date 11/28/2003
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
Predetermined Change
Control Plan Authorized		 No
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