The following data is part of a premarket notification filed by Chattanooga Group, Inc. with the FDA for Vectra Combo.
| Device ID | K982317 |
| 510k Number | K982317 |
| Device Name: | VECTRA COMBO |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | CHATTANOOGA GROUP, INC. 4717 ADAMS RD. P.O. BOX 4287 Hixson, TN 37343 |
| Contact | Cheryl G Dyer |
| Correspondent | Cheryl G Dyer CHATTANOOGA GROUP, INC. 4717 ADAMS RD. P.O. BOX 4287 Hixson, TN 37343 |
| Product Code | IMG |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | IMI |
| Subsequent Product Code | IPF |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-02 |
| Decision Date | 1999-02-01 |