The following data is part of a premarket notification filed by Restorative Therapies, Inc. with the FDA for Rt300 Fes Cycle Ergometer.
| Device ID | K162470 |
| 510k Number | K162470 |
| Device Name: | RT300 FES Cycle Ergometer |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | Restorative Therapies, Inc. 1434 Fleet St. Baltimore, MD 21231 |
| Contact | Andrew Barriskill |
| Correspondent | Andrew Barriskill Restorative Therapies, Inc. 1434 Fleet St. Baltimore, MD 21231 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-06 |
| Decision Date | 2017-07-11 |
| Summary: | summary |