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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 K932329
Device Name HOVEROUND POWER CHAIR
Applicant
Hoveround Corp.
1748 Independence Blvd.
Suite B1
Sarasota,  FL  34234
Applicant Contact DONALD L SHAPIRO
Correspondent
Hoveround Corp.
1748 Independence Blvd.
Suite B1
Sarasota,  FL  34234
Correspondent Contact DONALD L SHAPIRO
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/13/1993
Decision Date 03/28/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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