The following data is part of a premarket notification filed by Chattanooga Group, Inc. with the FDA for Intelect Model 120.
Device ID | K880235 |
510k Number | K880235 |
Device Name: | INTELECT MODEL 120 |
Classification | Stimulator, Muscle, Powered |
Applicant | CHATTANOOGA GROUP, INC. 101 MEMORIAL DR. Red Bank, TN 37405 |
Contact | Jerrell Duckworth |
Correspondent | Jerrell Duckworth CHATTANOOGA GROUP, INC. 101 MEMORIAL DR. Red Bank, TN 37405 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-20 |
Decision Date | 1988-04-08 |