The following data is part of a premarket notification filed by Chattanooga Group with the FDA for Compex Sport Plus.
Device ID | K083140 |
510k Number | K083140 |
Device Name: | COMPEX SPORT PLUS |
Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
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 | NGX |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-10-23 |
Decision Date | 2009-02-09 |
Summary: | summary |