Restorative Therapies, Inc.: FDA clearances and approvals
Restorative Therapies, Inc. has 10 FDA 510(k) clearances (first 2005, latest 2017), across 2 product codes in 2 review panels. Median 510(k) review time: 138 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 288 |
| 2017 | 1 | 308 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Restorative Therapies, Inc.'s cleared 510(k)s took a median 308 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZI | Stimulator, Neuromuscular, External Functional | 9 | 9 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
Review panels
- Neurology (9)
- Physical Medicine (1)
Most recent Restorative Therapies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162470 | RT300 FES cycle ergometer | GZI | 2017-07-11 | 308 |
| K160614 | Xcite Clinical Station | IPF | 2016-12-16 | 288 |
| K103370 | RT200 | GZI | 2011-04-05 | 139 |
| K103366 | RT600 | GZI | 2011-04-04 | 139 |
| K090750 | RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 | GZI | 2009-08-05 | 138 |
| K072398 | RT300-S AND RT300-SP FES CYCLE ERGOMETER | GZI | 2007-11-21 | 86 |
| K071486 | RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053 | GZI | 2007-09-10 | 103 |
| K071113 | RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 | GZI | 2007-07-05 | 76 |
| K060032 | RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 | GZI | 2006-03-10 | 64 |
| K050036 | FES CYCLE ERGOMETER, MODEL RT300-S | GZI | 2005-06-27 | 171 |
Recalls
openFDA lists no recalls under a recalling firm named Restorative Therapies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Restorative Therapies, Inc. have?
Restorative Therapies, Inc. has 10 FDA 510(k) clearances (first 2005, latest 2017), across 2 product codes in 2 review panels.
How long does FDA take to clear Restorative Therapies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Restorative Therapies, Inc.'s cleared 510(k)s is 138 days.
What devices does Restorative Therapies, Inc. make?
Its most frequent FDA product codes are GZI (Stimulator, Neuromuscular, External Functional, 9); IPF (Stimulator, Muscle, Powered, 1).
Has Restorative Therapies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Restorative Therapies, Inc. Related entities may recall under other names.
Next steps
- See all 10 Restorative Therapies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZI, Restorative Therapies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.