| Device Classification Name |
Stimulator, Neuromuscular, External Functional
|
| 510(k) Number |
K940759 |
| Device Name |
FORTE ES |
| Applicant |
| Chattanooga Group, Inc. |
| 4717 Adams Rd. |
| P.O. Box 489 |
|
Hixson,
TN
37343
|
|
| Applicant Contact |
GRAHAME R WATTS |
| Correspondent |
| Chattanooga Group, Inc. |
| 4717 Adams Rd. |
| P.O. Box 489 |
|
Hixson,
TN
37343
|
|
| Correspondent Contact |
GRAHAME R WATTS |
| Regulation Number | 882.5810 |
| Classification Product Code |
|
| Date Received | 02/18/1994 |
| Decision Date | 03/16/1995 |
| 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
|
|
|