The following data is part of a premarket notification filed by Chattanooga Group with the FDA for Vectra Epr System And Intelect Epr System.
| Device ID | K031077 |
| 510k Number | K031077 |
| Device Name: | VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | CHATTANOOGA GROUP 4717 ADAMS RD. Hixson, TN 37343 |
| Contact | Cheryl L Bagwell |
| Correspondent | Cheryl L Bagwell CHATTANOOGA GROUP 4717 ADAMS RD. Hixson, TN 37343 |
| Product Code | IMG |
| Subsequent Product Code | GZI |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | HCC |
| 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 | 2003-04-04 |
| Decision Date | 2003-12-11 |