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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 K954131
Device Name HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND
Applicant
Hoveround Corp.
8135 25th Ct. E.
Sarasota,  FL  34243
Applicant Contact THOMAS E KRUSE
Correspondent
Hoveround Corp.
8135 25th Ct. E.
Sarasota,  FL  34243
Correspondent Contact THOMAS E KRUSE
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/01/1995
Decision Date 06/06/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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