The following data is part of a premarket notification filed by Chattanooga Group with the FDA for Intelect Swd 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601.
| Device ID | K083433 |
| 510k Number | K083433 |
| Device Name: | INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 |
| Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Applicant | CHATTANOOGA GROUP 4717 ADAMS RD. Hixson, TN 37343 |
| Contact | Michael Treas |
| Correspondent | Michael Treas CHATTANOOGA GROUP 4717 ADAMS RD. Hixson, TN 37343 |
| Product Code | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-20 |
| Decision Date | 2009-03-18 |
| Summary: | summary |