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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 K100527
Device Name HOVEROUND TEKNIQUE, MODEL HD-6
Applicant
Hoveround Corp.
2151 Whitfield Industrial Way
Sarasota,  FL  34243
Applicant Contact TONY DIGIOVANNI
Correspondent
Hoveround Corp.
2151 Whitfield Industrial Way
Sarasota,  FL  34243
Correspondent Contact TONY DIGIOVANNI
Regulation Number890.3860
Classification Product Code
ITI  
Date Received02/24/2010
Decision Date 03/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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