| Device Classification Name |
Stimulator, Muscle, Powered
|
| 510(k) Number |
K934919 |
| Device Name |
THE SIGNATURE SERIES, MAGNUM 100 |
| Applicant |
| Progressive Electrical Therapeutics |
| 200 S. Alma |
|
Nevada,
MO
64772
|
|
| Correspondent |
| Progressive Electrical Therapeutics |
| 200 S. Alma |
|
Nevada,
MO
64772
|
|
| Regulation Number | 890.5850 |
| Classification Product Code |
|
| Date Received | 10/14/1993 |
| Decision Date | 04/06/1994 |
| 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
|
|
|