The following data is part of a premarket notification filed by Djo, Llc with the FDA for Empi Phoenix.
Device ID | K124016 |
510k Number | K124016 |
Device Name: | EMPI PHOENIX |
Classification | Stimulator, Muscle, Powered |
Applicant | DJO, LLC 1430 DECISION STREET Vista, CA 92081 |
Contact | Ken Fisher |
Correspondent | Ken Fisher DJO, LLC 1430 DECISION STREET Vista, CA 92081 |
Product Code | IPF |
Subsequent Product Code | GZJ |
Subsequent Product Code | NYN |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-27 |
Decision Date | 2013-05-06 |
Summary: | summary |