The following data is part of a premarket notification filed by Djo, Llc with the FDA for Compex Sport Elite 3.0.
| Device ID | K201653 |
| 510k Number | K201653 |
| Device Name: | Compex Sport Elite 3.0 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | DJO, LLC 1430 Decision Street Vista, CA 92081 |
| Contact | Michael Davis |
| Correspondent | Michael Davis DJO, LLC 1430 Decision Street Vista, CA 92081 |
| Product Code | NGX |
| Subsequent Product Code | NUH |
| Subsequent Product Code | NYN |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-18 |
| Decision Date | 2020-11-27 |