The following data is part of a premarket notification filed by Chattanooga Group with the FDA for Compex Rehab.
Device ID | K090632 |
510k Number | K090632 |
Device Name: | COMPEX REHAB |
Classification | Stimulator, Muscle, Powered |
Applicant | CHATTANOOGA GROUP 1430 DECISION STREET Vista, CA 92081 |
Contact | Nora C.r. York |
Correspondent | Nora C.r. York CHATTANOOGA GROUP 1430 DECISION STREET Vista, CA 92081 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-03-09 |
Decision Date | 2009-06-01 |
Summary: | summary |