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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
Device Name HOVERROUND TEKNIQUE
Applicant
HOVEROUND CORP.
2151 WHITFIELD INDUSTRIAL WAY
SARASOTA,  FL  34243
Applicant Contact ROBERT MUNCH
Correspondent
HOVEROUND CORP.
2151 WHITFIELD INDUSTRIAL WAY
SARASOTA,  FL  34243
Correspondent Contact ROBERT MUNCH
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/04/2012
Decision Date 05/07/2013
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
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