| Device Classification Name |
Stimulator, Muscle, Powered
|
| 510(k) Number |
K862685 |
| Device Name |
MUSCLE MASTER (BIPOLAR STIMULATOR) |
| Applicant |
| Modern Systems Technology, Inc. |
| P.O. Box 87 |
|
Beaverton,
OR
97075
|
|
| Applicant Contact |
VAN DIJK |
| Correspondent |
| Modern Systems Technology, Inc. |
| P.O. Box 87 |
|
Beaverton,
OR
97075
|
|
| Correspondent Contact |
VAN DIJK |
| Regulation Number | 890.5850 |
| Classification Product Code |
|
| Date Received | 07/15/1986 |
| Decision Date | 11/25/1986 |
| 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
|
|
|