| Device Classification Name |
Components, Wheelchair
|
| 510(k) Number |
K890178 |
| Device Name |
WHEELCHAIR STUMP SUPPORT |
| Applicant |
| Gerber Chair Mates, Inc. |
| 1171 Ringling Ave. |
|
Johnstown,
PA
15902
|
|
| Applicant Contact |
JAMES R GERBER |
| Correspondent |
| Gerber Chair Mates, Inc. |
| 1171 Ringling Ave. |
|
Johnstown,
PA
15902
|
|
| Correspondent Contact |
JAMES R GERBER |
| Regulation Number | 890.3920 |
| Classification Product Code |
|
| Date Received | 01/17/1989 |
| Decision Date | 09/11/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| 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
|
|
|