Data / Medical devices / United States / Restorative Therapies Inc.
Restorative Therapies Inc.: FDA-registered device maker in Nottingham, MD, United States, 4 510(k) clearances
Restorative Therapies Inc. is registered with the FDA (registration 3004733458) in Nottingham, MD, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 11, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004733458
- Address
- 8098 Sandpiper Circle Suite M, Nottingham, MD, United States, 21236
- Owner or operator
- RESTORATIVE THERAPIES INC. (9066635)
- Roles
- Manufacturer
- First device listed
- December 20, 2007
- Registered through
- 2026
- Brand names listed
- RT200 FES elliptical ergometer, RT300 FES Cycle Ergometer, RT300 non-FES Ergometer, RT600 FES stepper ergometer, Xcite FES system
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Exerciser, Powered | BXB | 1 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Neuromuscular, External Functional | GZI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 11, 2017 | K162470 | RT300 FES cycle ergometer | GZI | Substantially Equivalent | Restorative Therapies, Inc. | accessdata.fda.gov |
| December 16, 2016 | K160614 | Xcite Clinical Station | IPF | Substantially Equivalent | Restorative Therapies, Inc. | accessdata.fda.gov |
| April 5, 2011 | K103370 | RT200 | GZI | Substantially Equivalent | Restorative Therapies, Inc. | accessdata.fda.gov |
| April 4, 2011 | K103366 | RT600 | GZI | Substantially Equivalent | Restorative Therapies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Neuromuscular, External Functional
- All makers of Exerciser, Powered
- All makers of Stimulator, Muscle, Powered
Updated July 11, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.