| Device Classification Name |
Stimulator, Muscle, Powered
|
| 510(k) Number |
K896836 |
| Device Name |
EXCEL STIM |
| Applicant |
| Excel Tech. , Ltd. |
| 2892 Portland Dr. |
|
Oakville,Ontario,
CA
L6H 5W8
|
|
| Applicant Contact |
RAY J GAGNE |
| Correspondent |
| Excel Tech. , Ltd. |
| 2892 Portland Dr. |
|
Oakville,Ontario,
CA
L6H 5W8
|
|
| Correspondent Contact |
RAY J GAGNE |
| Regulation Number | 890.5850 |
| Classification Product Code |
|
| Date Received | 11/13/1989 |
| Decision Date | 02/20/1990 |
| 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
|
|
|