510(k) · Cleared
Recalled · 2008Walkaide System, Models 20-0100, 20-0310, 20-1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Neurotronics, Inc. · GZI Stimulator, Neuromuscular, External Functional
Cleared on Sep 21, 2005 as substantially equivalent to K974514 (Neuromotion, Inc., 1998) after a 27-day review. Its family tree reaches back 2 generations to 1980. 16 later devices descend from it. It has been recalled once.
- Decided
- Sep 21, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- GZI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K800380 (1980). 5 ancestors in all. 16 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK800380 Fes Orthosis Model NO. 2000Empi · 1980
- 1 generation backK974514 External Functional Neuromuscular StimulatorNeuromotion, Inc. · 1998
- This deviceK052329 Walkaide System, Models 20-0100, 20-0310, 20-1000Innovative Neurotronics, Inc. · 2005
- Descendant · cites it directly · 14 of its ownK123972 Walkaide SystemInnovative Neurotronics, Inc. · 2013
- Descendant · 2 generations on · 10 of its ownK140886 Walkaide SystemInnovative Neurotronics, Inc. · 2014
- Descendant · cites it directly · 10 of its ownK122784 Ness L300 System Kit, Lef Model LG3-5100; Ness L300 System Kit…Bioness, Inc. · 2012
- Descendant · 2 generations on · 9 of its ownK162407 L300 Go SystemBioness, Inc. · 2017
- Descendant · 3 generations on · 7 of its ownK173682 L300 Go SystemBioness, Inc. · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K123972Walkaide SystemInnovative Neurotronics, Inc. · 2013 · cites it directly14descendants
- K140886Walkaide SystemInnovative Neurotronics, Inc. · 2014 · 2 generations on10descendants
- K122784Ness L300 System Kit, Lef Model LG3-5100; Ness L300 System Kit, Right Model LG3-5000…Bioness, Inc. · 2012 · cites it directly10descendants
- K162407L300 Go SystemBioness, Inc. · 2017 · 2 generations on9descendants
- K173682L300 Go SystemBioness, Inc. · 2018 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K800380 | Fes Orthosis Model NO. 2000 | Empi | 1980 | — |
| −1 | K974514 | External Functional Neuromuscular Stimulator | Neuromotion, Inc. | 1998 | — |
| 0 (this device) | K052329 | Walkaide System, Models 20-0100, 20-0310, 20-1000 | Innovative Neurotronics, Inc. | 2005 | — |
| +1 | K123972 | Walkaide System | Innovative Neurotronics, Inc. | 2013 | — |
| +2 | K140886 | Walkaide System | Innovative Neurotronics, Inc. | 2014 | — |
| +1 | K122784 | Ness L300 System Kit, Lef Model LG3-5100; Ness L300 System Kit, Right Model… | Bioness, Inc. | 2012 | — |
| +2 | K162407 | L300 Go System | Bioness, Inc. | 2017 | — |
| +3 | K173682 | L300 Go System | Bioness, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K974514 | External Functional Neuromuscular StimulatorSummary page 1…nctional Stimulator Classification Number: 21 CFR 882.5810 Product Code: GZI 3. PREDICATE DEVICES Neuromotion WalkAide System- K974514 4. INTENDED USE The Innovative Neurotronics WalkAide System is intended to address the lack of ankle dors… | 1998 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 6, 2008 | Not classified | Z-1435-2009 | Nonconforming Material/Component | Knob responsible for regulating the amount of stimulation administered by the WalkAide System control unit may fall off while device is in use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 17.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K123972 (Innovative Neurotronics, Inc., 2013) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K974514.
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 Innovative Neurotronics WalkAide External Functional Neuromuscular Stimulator (WalkAide System) is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide System electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/ retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052329: Walkaide System, Models 20-0100, 20-0310, 20-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052329
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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