The following data is part of a premarket notification filed by Fit-pro Kft Ltd. with the FDA for E-fit Ef-1280 Ems Machine.
| Device ID | K133225 |
| 510k Number | K133225 |
| Device Name: | E-FIT EF-1280 EMS MACHINE |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | FIT-PRO KFT LTD. 144 RESEARCH DRIVE Hampton, VA 23666 |
| Contact | Rhonda Alexander, M.s., M.p.a. |
| Correspondent | Rhonda Alexander, M.s., M.p.a. FIT-PRO KFT LTD. 144 RESEARCH DRIVE Hampton, VA 23666 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-21 |
| Decision Date | 2014-10-24 |
| Summary: | summary |