The following data is part of a premarket notification filed by Fit-pro Ltd. with the FDA for E-fit Infinity System (ef-2090 Controller And Ef-100 Unit).
| Device ID | K202148 |
| 510k Number | K202148 |
| Device Name: | E-Fit Infinity System (EF-2090 Controller And EF-100 Unit) |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Fit-Pro Ltd. 7 Szabadsag Ter Budapest, HU 1054 |
| Contact | Janos Papp |
| Correspondent | Janos Papp Fit-Pro Ltd. 7 Szabadsag Ter Budapest, HU 1054 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-03 |
| Decision Date | 2021-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05999887598029 | K202148 | 000 |