510(k) · Cleared
ClearedRT300 FES cycle ergometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Restorative Therapies, Inc. · GZI Stimulator, Neuromuscular, External Functional
Cleared on Jul 11, 2017 as substantially equivalent to K090750 (Restorative Therapies, Inc., 2009) and 1 other predicate after a 308-day review. Its family tree reaches back 7 generations to 1984.
- Decided
- Jul 11, 2017
- Review
- 308 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K841112 (1984). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK841112 Tti Rehabilatation Gym SysTherapeutic Technologies, Inc. · 1984
- 6 generations backK060032 RT300-S, Model FA100052; RT300-SP, Model FA100053Restorative Therapies, Inc. · 2006
- 5 generations backK071113 RT300-S, Model FA100052, RT300-SP (Pediatric Version), Model FA100053Restorative Therapies, Inc. · 2007
- 4 generations backK071486 RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053Restorative Therapies, Inc. · 2007
- 3 generations backK072398 RT300-S and RT300-SP Fes Cycle ErgometerRestorative Therapies, Inc. · 2007
- 2 generations backK090750 RT300-SL, Model FA100052; RT300-Slsa, Model FA104581Restorative Therapies, Inc. · 2009
- 1 generation backK160614 Xcite Clinical StationRestorative Therapies, Inc. · 2016
- This deviceK162470 RT300 FES cycle ergometerRestorative Therapies, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K841112 | Tti Rehabilatation Gym Sys | Therapeutic Technologies, Inc. | 1984 | — |
| −6 | K060032 | RT300-S, Model FA100052; RT300-SP, Model FA100053 | Restorative Therapies, Inc. | 2006 | — |
| −5 | K071113 | RT300-S, Model FA100052, RT300-SP (Pediatric Version), Model FA100053 | Restorative Therapies, Inc. | 2007 | — |
| −4 | K071486 | RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053 | Restorative Therapies, Inc. | 2007 | — |
| −3 | K072398 | RT300-S and RT300-SP Fes Cycle Ergometer | Restorative Therapies, Inc. | 2007 | — |
| −2 | K090750 | RT300-SL, Model FA100052; RT300-Slsa, Model FA104581 | Restorative Therapies, Inc. | 2009 | — |
| −1 | K160614 | Xcite Clinical Station | Restorative Therapies, Inc. | 2016 | — |
| 0 (this device) | K162470 | RT300 FES cycle ergometer | Restorative Therapies, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GZI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GZI device
- #1 K243828 Cionic Neural Sleeve (NS-200)score 12.9 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090750 | RT300-SL, Model FA100052; RT300-Slsa, Model FA104581Summary page 4…Class: II Product Code: GZI (3) Identification of the legally marketed device to which the submitter claims equivalence: RESTORATIVE THERAPIES, INC. product: “RT300”, K090750 RESTORATIVE THERAPIES, INC. product: “Xcite Clinical Station”, K160614 (4) A description of the device that is the subject of th… | 2009 |
| * | K160614 | Xcite Clinical Station Cleared while this submission was under review Summary page 4…d device to which the submitter claims equivalence: RESTORATIVE THERAPIES, INC. product: “RT300”, K090750 RESTORATIVE THERAPIES, INC. product: “Xcite Clinical Station”, K160614 (4) A description of the device that is the subject of the premarket notification submission. The RT300 is a Functional Electri… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 9 ancestors has a recall.
- 3 other devices also cite its predicate K090750.
How does its category compare?
All GZI devicesGZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZI
110in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZI
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZI
3in 2025
MAUDE reports naming product code GZI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 81 | 0 | 1 |
| 2008 | 1 | — | 1 | 2 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 6 | 139 | 0 | 3 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 299 | 0 | 2 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 6 | 168 | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 4 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 4 | 110 | 0 | 3 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RT300 is intended for general rehabilitation for:
1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Maintaining or increasing range of motion
5. Muscle re-education
The RT300 pediatric version is intended for population ages 4 to 12 years.
The RT300 is intended for use with a surface electrical stimulation garment for population ages 12 and above.
The RT300 is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162470: RT300 FES cycle ergometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162470
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026