The following data is part of a premarket notification filed by Chattanooga Group with the FDA for Vectra Transportable Combo And Stim (specialty Line Dealers); Intelect Transportable Combo And Stim (general Line Dealer.
Device ID | K040285 |
510k Number | K040285 |
Device Name: | VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER |
Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
Applicant | CHATTANOOGA GROUP 4717 ADAMS RD. Hixson, TN 37343 |
Contact | Mick Davis |
Correspondent | Mick Davis CHATTANOOGA GROUP 4717 ADAMS RD. Hixson, TN 37343 |
Product Code | IMG |
Subsequent Product Code | GZI |
Subsequent Product Code | GZJ |
Subsequent Product Code | IPF |
CFR Regulation Number | 890.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-02-06 |
Decision Date | 2004-04-12 |