510(k) · Cleared
Recalled · Class II · 2022MyoCycle MC-2 (Home / Home + / Pro / 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, 2022 as substantially equivalent to K170132 (Myolyn, LLC, 2017) after a 130-day review. Its family tree reaches back 3 generations to 1984. It has been recalled once.
- Decided
- Apr 25, 2022
- Review
- 130 days
- Class
- Class II
- Product code
- GZI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K841112 (1984). No later device cites it as a predicate yet.
- Root · 3 generations backK841112 Tti Rehabilatation Gym SysTherapeutic Technologies, Inc. · 1984
- 2 generations backK050036 Fes Cycle Ergometer, Model RT300-SRestorative Therapies, Inc. · 2005
- 1 generation backK170132 MyoCycle Home, MyoCycle ProMyolyn, LLC · 2017
- This deviceK213925 MyoCycle MC-2 (Home / Home + / Pro / Pro +)Myolyn, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K841112 | Tti Rehabilatation Gym Sys | Therapeutic Technologies, Inc. | 1984 | — |
| −2 | K050036 | Fes Cycle Ergometer, Model RT300-S | Restorative Therapies, Inc. | 2005 | — |
| −1 | K170132 | MyoCycle Home, MyoCycle Pro | Myolyn, LLC | 2017 | — |
| 0 (this device) | K213925 | MyoCycle MC-2 (Home / Home + / Pro / Pro +) | Myolyn, LLC | 2022 | — |
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 |
|---|---|---|---|
| * | K170132 | MyoCycle Home, MyoCycle ProSummary page 4…rketed device to which the submitter claims equivalence: Manufacturer: MYOLYN Product: MyoCycle MC-HP-1 (Home / Pro) 510(k) number: K170132 Device class: 2 (4) A description of the device that is subject of the premarket notification submission: The Myo… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 19, 2022 | Class II | Z-1523-2022 | Device Design | Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 3 companies; a new generation was cleared every 11.8 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All GZI devicesGZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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
5. Muscle re-education
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213925: MyoCycle MC-2 (Home / Home + / Pro / Pro +).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213925
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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