| Device Classification Name |
Wheelchair, Powered
|
| 510(k) Number |
K933863 |
| Device Name |
S500 SEATING SYSTEM |
| Applicant |
| Fortress Scientific , Ltd. |
| C/O Foley & Lardner |
| 3000 K St., NW |
|
Washington,
DC
20007
|
|
| Applicant Contact |
ILENE KNABLE GOTTS |
| Correspondent |
| Fortress Scientific , Ltd. |
| C/O Foley & Lardner |
| 3000 K St., NW |
|
Washington,
DC
20007
|
|
| Correspondent Contact |
ILENE KNABLE GOTTS |
| Regulation Number | 890.3860 |
| Classification Product Code |
|
| Date Received | 08/06/1993 |
| 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
|
|
|