| Device Classification Name |
Stimulator, Muscle, Powered
|
| 510(k) Number |
K872207 |
| Device Name |
MS-108, POWERED MUSCLE STIMULATOR |
| Applicant |
| Electro Med Supply, Inc. |
| P.O. Drawer 179 |
| 19207 Jayhawk Dr. |
|
Penn Valley,
CA
95946
|
|
| Applicant Contact |
THOMAS V DAIGLE |
| Correspondent |
| Electro Med Supply, Inc. |
| P.O. Drawer 179 |
| 19207 Jayhawk Dr. |
|
Penn Valley,
CA
95946
|
|
| Correspondent Contact |
THOMAS V DAIGLE |
| Regulation Number | 890.5850 |
| Classification Product Code |
|
| Date Received | 06/08/1987 |
| Decision Date | 10/06/1987 |
| 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
|
|
|