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 Number | 890.3860
|
Classification Product Code |
|
Date Received | 09/04/2012 |
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
|
|
|