| Device Classification Name |
Device, Biofeedback
|
| 510(k) Number |
K972487 |
| Device Name |
EMG RETRAINER |
| Applicant |
| Chattanooga Group, Inc. |
| 4717 Adams Rd. |
| P.O. Box 489 |
|
Hixson,
TN
37343
|
|
| Applicant Contact |
JOE ELROD |
| Correspondent |
| Chattanooga Group, Inc. |
| 4717 Adams Rd. |
| P.O. Box 489 |
|
Hixson,
TN
37343
|
|
| Correspondent Contact |
JOE ELROD |
| Regulation Number | 882.5050 |
| Classification Product Code |
|
| Date Received | 07/02/1997 |
| Decision Date | 09/26/1997 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|