The following data is part of a premarket notification filed by Medovent Gmbh with the FDA for Reaxon Plus.
| Device ID | K143711 |
| 510k Number | K143711 |
| Device Name: | Reaxon Plus |
| Classification | Cuff, Nerve |
| Applicant | MEDOVENT GMBH FRIEDRICH-KOENIG-STR. 3 Mainz, DE 55129 |
| Contact | Thomas Freier |
| Correspondent | Thomas Freier MEDOVENT GMBH FRIEDRICH-KOENIG-STR. 3 Mainz, DE 55129 |
| Product Code | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-29 |
| Decision Date | 2015-12-02 |
| Summary: | summary |