The following data is part of a premarket notification filed by Restorative Therapies Inc. with the FDA for Fes Cycle Ergometer, Model Rt300-s.
| Device ID | K050036 |
| 510k Number | K050036 |
| Device Name: | FES CYCLE ERGOMETER, MODEL RT300-S |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | RESTORATIVE THERAPIES INC. 2363 BOSTON ST. Baltimore, MD 21224 |
| Contact | Andrew Barriskill |
| Correspondent | Andrew Barriskill RESTORATIVE THERAPIES INC. 2363 BOSTON ST. Baltimore, MD 21224 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-07 |
| Decision Date | 2005-06-27 |
| Summary: | summary |