| Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
| 510(k) Number |
K933197 |
| Device Name |
THE SIGNATURE SERIES, M IV |
| Applicant |
| Progressive Electrical Therapeutics |
| 122 W. Walnut |
|
Nevada,
MO
64772
|
|
| Applicant Contact |
GARY HUDDLESTON |
| Correspondent |
| Progressive Electrical Therapeutics |
| 122 W. Walnut |
|
Nevada,
MO
64772
|
|
| Correspondent Contact |
GARY HUDDLESTON |
| Regulation Number | 882.5890 |
| Classification Product Code |
|
| Date Received | 07/01/1993 |
| Decision Date | 06/02/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|