The following data is part of a premarket notification filed by Chattanooga Group, Inc. with the FDA for Forte Es-400.
| Device ID | K953615 |
| 510k Number | K953615 |
| Device Name: | FORTE ES-400 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | CHATTANOOGA GROUP, INC. 4717 ADAMS RD. P.O. BOX 4287 Hixson, TN 37343 |
| Contact | Grahame R Watts |
| Correspondent | Grahame R Watts CHATTANOOGA GROUP, INC. 4717 ADAMS RD. P.O. BOX 4287 Hixson, TN 37343 |
| Product Code | IPF |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-03 |
| Decision Date | 1995-10-27 |