The following data is part of a premarket notification filed by Djo, Llc with the FDA for Compex Wireless Usa.
| Device ID | K170903 |
| 510k Number | K170903 |
| Device Name: | Compex Wireless USA |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | DJO, LLC 1430 Decision Street Vista, CA 92081 |
| Contact | Natalia Shirina |
| Correspondent | Natalia Shirina 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 | 2017-03-28 |
| Decision Date | 2017-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190446253310 | K170903 | 000 |