510(k) · Cleared
ClearedRT300-S and RT300-SP 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 Nov 21, 2007 as substantially equivalent to K071486 (Restorative Therapies, Inc., 2007) after an 86-day review. Its family tree reaches back 4 generations to 1984. 5 later devices descend from it.
- Decided
- Nov 21, 2007
- Review
- 86 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K841112 (1984). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK841112 Tti Rehabilatation Gym SysTherapeutic Technologies, Inc. · 1984
- 3 generations backK060032 RT300-S, Model FA100052; RT300-SP, Model FA100053Restorative Therapies, Inc. · 2006
- 2 generations backK071113 RT300-S, Model FA100052, RT300-SP (Pediatric Version), Model FA100053Restorative Therapies, Inc. · 2007
- 1 generation backK071486 RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053Restorative Therapies, Inc. · 2007
- This deviceK072398 RT300-S and RT300-SP Fes Cycle ErgometerRestorative Therapies, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK090750 RT300-SL, Model FA100052; RT300-Slsa, Model FA104581Restorative Therapies, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK160614 Xcite Clinical StationRestorative Therapies, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK162470 RT300 FES cycle ergometerRestorative Therapies, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK103370 RT200Restorative Therapies, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK103366 RT600Restorative Therapies, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K090750RT300-SL, Model FA100052; RT300-Slsa, Model FA104581Restorative Therapies, Inc. · 2009 · cites it directly4descendants
- K160614Xcite Clinical StationRestorative Therapies, Inc. · 2016 · 2 generations on1descendant
- K162470RT300 FES cycle ergometerRestorative Therapies, Inc. · 2017 · 2 generations on0descendants
- K103370RT200Restorative Therapies, Inc. · 2011 · 2 generations on0descendants
- K103366RT600Restorative Therapies, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K841112 | Tti Rehabilatation Gym Sys | Therapeutic Technologies, Inc. | 1984 | — |
| −3 | K060032 | RT300-S, Model FA100052; RT300-SP, Model FA100053 | Restorative Therapies, Inc. | 2006 | — |
| −2 | K071113 | RT300-S, Model FA100052, RT300-SP (Pediatric Version), Model FA100053 | Restorative Therapies, Inc. | 2007 | — |
| −1 | K071486 | RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053 | Restorative Therapies, Inc. | 2007 | — |
| 0 (this device) | K072398 | RT300-S and RT300-SP Fes Cycle Ergometer | Restorative Therapies, Inc. | 2007 | — |
| +1 | K090750 | RT300-SL, Model FA100052; RT300-Slsa, Model FA104581 | Restorative Therapies, Inc. | 2009 | — |
| +2 | K160614 | Xcite Clinical Station | Restorative Therapies, Inc. | 2016 | — |
| +2 | K162470 | RT300 FES cycle ergometer | Restorative Therapies, Inc. | 2017 | — |
| +2 | K103370 | RT200 | Restorative Therapies, Inc. | 2011 | — |
| +2 | K103366 | RT600 | Restorative Therapies, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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? (1)
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 |
|---|---|---|---|
| * | K071486 | RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053 Cleared while this submission was under review Summary page 1…me:Powered Muscle Stimulator (3) Identification of the legally marketed device to which the submitter claims equivalence: RESTORATIVE THERAPIES, INC. product: "RT300", K071486, a class 2 device (4) A description of the device that is the subject of the premarket notification submission. The RT300 is a… | 2007 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090750 | RT300-SL, Model FA100052; RT300-Slsa, Model FA104581 | 2009 | 4 |
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 23 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K090750 (Restorative Therapies, Inc., 2009) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GZI devicesGZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 adult and pediatric versions are 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
The RT300 pediatric version is intended for population ages 4 to 12 years.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072398 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072398: RT300-S and RT300-SP Fes Cycle Ergometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072398
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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