| Device Classification Name |
Wheelchair, Mechanical
|
| 510(k) Number |
K881051 |
| Device Name |
SAFETY PLUS MODEL 501 |
| Applicant |
| Safety Rehab Systems, Inc. |
| 147 Eady Ct. |
|
Elyria,
OH
44035
|
|
| Applicant Contact |
ROBERT DAUGHERTY |
| Correspondent |
| Safety Rehab Systems, Inc. |
| 147 Eady Ct. |
|
Elyria,
OH
44035
|
|
| Correspondent Contact |
ROBERT DAUGHERTY |
| Regulation Number | 890.3850 |
| Classification Product Code |
|
| Date Received | 03/11/1988 |
| Decision Date | 03/21/1988 |
| 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
|
|
|