The following data is part of a premarket notification filed by Fast Fit Llc with the FDA for Fastfit Ems System.
| Device ID | K192161 |
| 510k Number | K192161 |
| Device Name: | FastFit EMS System |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Fast Fit LLC 450 Park Avenue 31st Floor New York, NY 10022 |
| Contact | Lisa Falcone |
| Correspondent | Sigi Caron Biologics And Medical Device Consulting Group 20370 Skyhawk Lane Topanga, CA 90290 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-09 |
| Decision Date | 2020-01-22 |