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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 K122707
Model XHD MK-V
Device Name HOVERROUND TEKNIQUE
Original Applicant
HOVEROUND CORP.
2151 whitfield industrial way
sarasota,  FL  34243
Original Contact robert munch
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/04/2012
Decision Date 05/07/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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