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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transport, Patient, Powered
510(k) Number K093946
Device Name HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2
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 Number890.5150
Classification Product Code
ILK  
Date Received12/23/2009
Decision Date 03/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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