The following data is part of a premarket notification filed by Redplane Ag with the FDA for Elexoma Medic.
| Device ID | K070412 |
| 510k Number | K070412 |
| Device Name: | ELEXOMA MEDIC |
| Classification | Cranial Electrotherapy Stimulator To Treat Depression |
| Applicant | REDPLANE AG BAARERSTRASSE 8 Zug, CH 6300 |
| Contact | Jaen Labuschagne |
| Correspondent | Jaen Labuschagne REDPLANE AG BAARERSTRASSE 8 Zug, CH 6300 |
| Product Code | JXK |
| CFR Regulation Number | 882.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-12 |
| Decision Date | 2008-05-21 |