The following data is part of a premarket notification filed by Casgarum Investment, S.l. with the FDA for Flix-ems.
| Device ID | K181419 |
| 510k Number | K181419 |
| Device Name: | FLIX-EMS |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Casgarum Investment, S.L. Calle Real, 17 Bº E Illescas, ES 45200 |
| Contact | Rafael Castillo |
| Correspondent | Rafael Castillo Casgarum Investment, S.L. Calle Real, 17 Bº E Illescas, ES 45200 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-31 |
| Decision Date | 2019-05-14 |
| Summary: | summary |