Device Classification Name |
Wheelchair, Mechanical
|
510(k) Number |
K111636 |
Device Name |
REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM |
Applicant |
GUNNELL, INC. |
8440 STATE |
P.O. BOX 308 |
MILLINGTON,
MI
48746
|
|
Applicant Contact |
ANDREW EVANCHO |
Correspondent |
GUNNELL, INC. |
8440 STATE |
P.O. BOX 308 |
MILLINGTON,
MI
48746
|
|
Correspondent Contact |
ANDREW EVANCHO |
Regulation Number | 890.3850
|
Classification Product Code |
|
Date Received | 06/13/2011 |
Decision Date | 04/03/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|