The following data is part of a premarket notification filed by Chattanooga Group, Inc. with the FDA for Forte, Models Cps 400 Stim, Cps 200 Stim.
Device ID | K982828 |
510k Number | K982828 |
Device Name: | FORTE, MODELS CPS 400 STIM, CPS 200 STIM |
Classification | Stimulator, Muscle, Powered |
Applicant | CHATTANOOGA GROUP, INC. 4717 ADAMS RD. Hixson, TN 37343 |
Contact | Joe Elrod |
Correspondent | Joe Elrod CHATTANOOGA GROUP, INC. 4717 ADAMS RD. Hixson, TN 37343 |
Product Code | IPF |
Subsequent Product Code | GZJ |
Subsequent Product Code | LIH |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-11 |
Decision Date | 1998-11-06 |