| Device Classification Name |
Stimulator, Muscle, Powered
|
| 510(k) Number |
K862486 |
| Device Name |
MS-159 ELECTRONIC MUSCLE STIMULATOR |
| Applicant |
| Electro Med Supply, Inc. |
| P.O. Drawer 179 |
| 19207 Jayhawk Dr. |
|
Penn Valley,
CA
95946
|
|
| Applicant Contact |
THOMAS DAIGLE |
| Correspondent |
| Electro Med Supply, Inc. |
| P.O. Drawer 179 |
| 19207 Jayhawk Dr. |
|
Penn Valley,
CA
95946
|
|
| Correspondent Contact |
THOMAS DAIGLE |
| Regulation Number | 890.5850 |
| Classification Product Code |
|
| Date Received | 06/30/1986 |
| Decision Date | 07/16/1986 |
| 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
|
|
|