The following data is part of a premarket notification filed by G.tec Medical Engineering Gmbh with the FDA for G.estim Fes.
| Device ID | K200088 |
| 510k Number | K200088 |
| Device Name: | G.Estim FES |
| Classification | Stimulator, Muscle, Powered |
| Applicant | g.tec Medical Engineering GmbH Siemingerstrasse 14 Schiedlberg, AT 4521 |
| Contact | Christoph Guger |
| Correspondent | Christoph Guger g.tec Medical Engineering GmbH Siemingerstrasse 14 Schiedlberg, AT 4521 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-15 |
| Decision Date | 2020-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBCI11700 | K200088 | 000 |