510(k) · Cleared
ClearedModification to:Ness L300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ness-Neuromuscular Electrical Stimulation Systems · GZI Stimulator, Neuromuscular, External Functional
Cleared on Feb 28, 2008 as substantially equivalent to K053468 (Ness-Neuromuscular Electrical Stimulation Systems, 2006) after a 30-day review. Its family tree reaches back 4 generations to 1980. 16 later devices descend from it.
- Decided
- Feb 28, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K800380 (1980). 8 ancestors in all. 16 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK800380 Fes Orthosis Model NO. 2000Empi · 1980
- 3 generations backK974514 External Functional Neuromuscular StimulatorNeuromotion, Inc. · 1998
- 2 generations backK050991 The Odfs Dropped Foot StimulatorDepartment of Medical Physics and Biomedical Eng. · 2005
- 1 generation backK053468 NESS L300Ness-Neuromuscular Electrical Stimulation Systems · 2006
- This deviceK080219 Modification to:Ness L300Ness-Neuromuscular Electrical Stimulation Systems · 2008
- Descendant · cites it directly · 15 of its ownK103343 L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right…Bioness, Inc. · 2011
- Descendant · 2 generations on · 14 of its ownK123972 Walkaide SystemInnovative Neurotronics, Inc. · 2013
- Descendant · 3 generations on · 10 of its ownK140886 Walkaide SystemInnovative Neurotronics, Inc. · 2014
- 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- K103343L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left)Bioness, Inc. · 2011 · cites it directly15descendants
- K123972Walkaide SystemInnovative Neurotronics, Inc. · 2013 · 2 generations on14descendants
- K140886Walkaide SystemInnovative Neurotronics, Inc. · 2014 · 3 generations on10descendants
- 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 |
|---|---|---|---|---|---|
| −4 | K800380 | Fes Orthosis Model NO. 2000 | Empi | 1980 | — |
| −3 | K974514 | External Functional Neuromuscular Stimulator | Neuromotion, Inc. | 1998 | — |
| −2 | K050991 | The Odfs Dropped Foot Stimulator | Department of Medical Physics and Biomedical Eng. | 2005 | — |
| −1 | K053468 | NESS L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2006 | — |
| 0 (this device) | K080219 | Modification to:Ness L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2008 | — |
| +1 | K103343 | L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left) | Bioness, Inc. | 2011 | — |
| +2 | K123972 | Walkaide System | Innovative Neurotronics, Inc. | 2013 | — |
| +3 | K140886 | Walkaide System | Innovative Neurotronics, Inc. | 2014 | — |
| +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 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K053468 | NESS L300Summary page 2…uromuscular stimulator 890.5850 Powered Muscle Stimulator Predicate Devices: Neuromuscular Electrical Stimulation Systems, Ltd.'s NESS L300 (K053468) Purpose of the Special 510(k) notice. The NESS L300 is a modification to the NESS L300 (K053468). Device description:… | 2006 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103343 | L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left) | 2011 | 15 |
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 28 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K103343 (Bioness, Inc., 2011) has gone furthest, with 15 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. 2008, 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 NESS L300 is intended to provide ankle dorsiflexion in individuals with drop foot following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot; thus, it may improve the individual's gait. The NESS L300 may also facilitate muscle re-education, prevent/retard disused atrophy, maintain or increase joint range of motion and increase local blood flow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080219: Modification to:Ness L300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080219
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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