The following data is part of a premarket notification filed by Chattanooga Group, Inc. with the FDA for Forte Us.
| Device ID | K941561 |
| 510k Number | K941561 |
| Device Name: | FORTE US |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | CHATTANOOGA GROUP, INC. 4717 ADAMS RD. P.O. BOX 489 Hixson, TN 37343 -0489 |
| Contact | Grahame R Watts |
| Correspondent | Grahame R Watts CHATTANOOGA GROUP, INC. 4717 ADAMS RD. P.O. BOX 489 Hixson, TN 37343 -0489 |
| Product Code | IMG |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-01 |
| Decision Date | 1994-06-20 |