The following data is part of a premarket notification filed by Djo, Llc with the FDA for Compex Wireless Usa.
| Device ID | K143551 |
| 510k Number | K143551 |
| Device Name: | Compex Wireless USA |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | DJO, LLC 1430 DECISION STREET Vista, CA 92081 -8553 |
| Contact | Gina Flores |
| Correspondent | Gina Flores DJO, LLC 1430 DECISION STREET Vista, CA 92081 -8553 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-15 |
| Decision Date | 2015-04-28 |
| Summary: | summary |