The following data is part of a premarket notification filed by Restorative Therapies Inc. with the FDA for Rt300-s, Model Fa100052, Rt300-sp (pediatric Version), Model Fa100053.
| Device ID | K071113 |
| 510k Number | K071113 |
| Device Name: | RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | RESTORATIVE THERAPIES INC. 907 SOUTH LAKEWOOD AVE. Baltimore, MD 21224 |
| Contact | Andrew Barriskill |
| Correspondent | Andrew Barriskill RESTORATIVE THERAPIES INC. 907 SOUTH LAKEWOOD AVE. Baltimore, MD 21224 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-20 |
| Decision Date | 2007-07-05 |
| Summary: | summary |