510(k) · Cleared
ClearedFes Cycle Ergometer, Model RT300-S
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 Jun 27, 2005 as substantially equivalent to K841112 (Therapeutic Technologies, Inc., 1984) after a 171-day review. Its family tree reaches back 1 generation to 1984. 2 later devices descend from it.
- Decided
- Jun 27, 2005
- Review
- 171 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K841112 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK841112 Tti Rehabilatation Gym SysTherapeutic Technologies, Inc. · 1984
- This deviceK050036 Fes Cycle Ergometer, Model RT300-SRestorative Therapies, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK170132 MyoCycle Home, MyoCycle ProMyolyn, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK213925 MyoCycle MC-2 (Home / Home + / Pro / Pro +)Myolyn, LLC · 2022 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K841112 | Tti Rehabilatation Gym Sys | Therapeutic Technologies, Inc. | 1984 | — |
| 0 (this device) | K050036 | Fes Cycle Ergometer, Model RT300-S | Restorative Therapies, Inc. | 2005 | — |
| +1 | K170132 | MyoCycle Home, MyoCycle Pro | Myolyn, LLC | 2017 | — |
| +2 | K213925 | MyoCycle MC-2 (Home / Home + / Pro / Pro +) | Myolyn, LLC | 2022 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K841112 | Tti Rehabilatation Gym SysSummary page 1…me:Powered Muscle Stimulator (3) Identification of the legally marketed device to which the submitter claims equivalence: THERAPEUTIC ALLIANCES, INC. product: "ERGYS", K841112, a class 2 device (4) A description of the device that is the subject of the premarket notification submission. The RT300-S is… | 1984 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170132 | MyoCycle Home, MyoCycle Pro | 2017 | 1 |
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?
How does its category compare?
All GZI devicesGZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years.
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-S (adult version) and RT300-SP (pediatric version) are intended for general rehabilitation for:
a. Relaxation of muscle spasms
b. Prevention or retardation of disuse atrophy
c. Increasing local blood circulation
d. Maintaining or increasing range of motion
The RT300-SP (pediatric version), is intended for population ages 4 to 12 years.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050036: Fes Cycle Ergometer, Model RT300-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050036
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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