510(k) · Cleared
ClearedEvoWalk 1.0 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evolution Devices, Inc. · GZI Stimulator, Neuromuscular, External Functional
Cleared on Dec 28, 2023 as substantially equivalent to K173682 (Bioness, Inc., 2018) after a 265-day review. Its family tree reaches back 10 generations to 1980.
- Decided
- Dec 28, 2023
- Review
- 265 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K800380 (1980). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK800380 Fes Orthosis Model NO. 2000Empi · 1980
- 6 generations between
- 3 generations backK140886 Walkaide SystemInnovative Neurotronics, Inc. · 2014
- 2 generations backK162407 L300 Go SystemBioness, Inc. · 2017
- 1 generation backK173682 L300 Go SystemBioness, Inc. · 2018
- This deviceK230997 EvoWalk 1.0 SystemEvolution Devices, Inc. · 2023
Show all 10 generations
- Root · 10 generations backK800380 Fes Orthosis Model NO. 2000Empi · 1980
- 9 generations backK974514 External Functional Neuromuscular StimulatorNeuromotion, Inc. · 1998
- 8 generations backK050991 The Odfs Dropped Foot StimulatorDepartment of Medical Physics and Biomedical Eng. · 2005
- 7 generations backK053468 NESS L300Ness-Neuromuscular Electrical Stimulation Systems · 2006
- 6 generations backK080219 Modification to:Ness L300Ness-Neuromuscular Electrical Stimulation Systems · 2008
- 5 generations backK103343 L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right…Bioness, Inc. · 2011
- 4 generations backK123972 Walkaide SystemInnovative Neurotronics, Inc. · 2013
- 3 generations backK140886 Walkaide SystemInnovative Neurotronics, Inc. · 2014
- 2 generations backK162407 L300 Go SystemBioness, Inc. · 2017
- 1 generation backK173682 L300 Go SystemBioness, Inc. · 2018
- This deviceK230997 EvoWalk 1.0 SystemEvolution Devices, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K800380 | Fes Orthosis Model NO. 2000 | Empi | 1980 | — |
| −9 | K974514 | External Functional Neuromuscular Stimulator | Neuromotion, Inc. | 1998 | — |
| −8 | K050991 | The Odfs Dropped Foot Stimulator | Department of Medical Physics and Biomedical Eng. | 2005 | — |
| −7 | K053468 | NESS L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2006 | — |
| −6 | K080219 | Modification to:Ness L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2008 | — |
| −5 | K103343 | L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left) | Bioness, Inc. | 2011 | — |
| −4 | K123972 | Walkaide System | Innovative Neurotronics, Inc. | 2013 | — |
| −3 | K140886 | Walkaide System | Innovative Neurotronics, Inc. | 2014 | — |
| −2 | K162407 | L300 Go System | Bioness, Inc. | 2017 | — |
| −1 | K173682 | L300 Go System | Bioness, Inc. | 2018 | — |
| 0 (this device) | K230997 | EvoWalk 1.0 System | Evolution Devices, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 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 |
|---|---|---|---|
| * | K173682 | L300 Go SystemSummary page 5…ular stimulator Class: II Classification Panel: Neurology Predicate devices: Company: Bioness Inc. Device: L300 Go System (K173682) Purpose of the traditional 510(k): This Traditional 510(k) is submitted to clear a new device, the EvoWalk 1.0 System. Device… | 2018 |
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 43 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 24 ancestors has a recall of any class.
- 1 other device also cites its predicate K173682.
How does its category compare?
All GZI devicesGZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 EvoWalk 1.0 System is intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The EvoWalk 1.0 System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual’s gait.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230997: EvoWalk 1.0 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230997
Report an extraction error
Are you the manufacturer?
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