510(k) · Cleared
ClearedMyoCycle Home, MyoCycle Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myolyn, LLC · GZI Stimulator, Neuromuscular, External Functional
Cleared on Apr 25, 2017 as substantially equivalent to K050036 (Restorative Therapies, Inc., 2005) after a 98-day review. Its family tree reaches back 2 generations to 1984. 1 later device descends from it.
- Decided
- Apr 25, 2017
- Review
- 98 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K841112 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK841112 Tti Rehabilatation Gym SysTherapeutic Technologies, Inc. · 1984
- 1 generation backK050036 Fes Cycle Ergometer, Model RT300-SRestorative Therapies, Inc. · 2005
- This deviceK170132 MyoCycle Home, MyoCycle ProMyolyn, LLC · 2017
- Descendant · cites it directly · 0 of its ownK213925 MyoCycle MC-2 (Home / Home + / Pro / Pro +)Myolyn, LLC · 2022 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K213925MyoCycle MC-2 (Home / Home + / Pro / Pro +)Myolyn, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K841112 | Tti Rehabilatation Gym Sys | Therapeutic Technologies, Inc. | 1984 | — |
| −1 | K050036 | Fes Cycle Ergometer, Model RT300-S | Restorative Therapies, Inc. | 2005 | — |
| 0 (this device) | K170132 | MyoCycle Home, MyoCycle Pro | Myolyn, LLC | 2017 | — |
| +1 | K213925 | MyoCycle MC-2 (Home / Home + / Pro / Pro +) | Myolyn, LLC | 2022 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K050036 | Fes Cycle Ergometer, Model RT300-SSummary page 4…ed device to which the submitter claims equivalence: Manufacturer: Restorative Therapies Inc. Product: RT300-S 510(k) number: K050036 Device class: 2 (4) A description of the device that is subject of the premarket notification submission:… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213925 | MyoCycle MC-2 (Home / Home + / Pro / Pro +) | 2022 | 0 |
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 3 companies; a new generation was cleared every 21.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K213925 (Myolyn, LLC, 2022) has gone furthest, with 0 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. 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 MyoCycle 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170132: MyoCycle Home, MyoCycle Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170132
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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