The following data is part of a premarket notification filed by Chattanooga Group, Inc. with the FDA for Intelect, Model 245.
Device ID | K911733 |
510k Number | K911733 |
Device Name: | INTELECT, MODEL 245 |
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 | Grahame R Watts |
Correspondent | Grahame R Watts CHATTANOOGA GROUP, INC. 4717 ADAMS RD. P.O. BOX 4287 Hixson, TN 37343 |
Product Code | IMG |
CFR Regulation Number | 890.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-17 |
Decision Date | 1991-12-17 |