Restorative Therapies Inc.
Nottingham, MD, US
RESTORATIVE THERAPIES INC. appears in FDA device records in Nottingham, MD. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Restorative Therapies Inc. between 2005 and 2017. The busiest year on record is 2007, with 3. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 3 |
| 2009 | 1 |
| 2011 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162470 | RT300 FES cycle ergometer | GZI | Substantially Equivalent | |
| K160614 | Xcite Clinical Station | IPF | Substantially Equivalent | |
| K103370 | RT200 | GZI | Substantially Equivalent | |
| K103366 | RT600 | GZI | Substantially Equivalent | |
| K090750 | RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 | GZI | Substantially Equivalent | |
| K072398 | RT300-S AND RT300-SP FES CYCLE ERGOMETER | GZI | Substantially Equivalent | |
| K071486 | RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053 | GZI | Substantially Equivalent | |
| K071113 | RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 | GZI | Substantially Equivalent | |
| K060032 | RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 | GZI | Substantially Equivalent | |
| K050036 | FES CYCLE ERGOMETER, MODEL RT300-S | GZI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004733458 | 3004733458 | RESTORATIVE THERAPIES INC. | 8098 Sandpiper Circle, Nottingham, MD 21236 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain