510(k) · Cleared
ClearedL300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioness, Inc. · GZI Stimulator, Neuromuscular, External Functional
Cleared on Apr 29, 2011 as substantially equivalent to K080219 (Ness-Neuromuscular Electrical Stimulation Systems, 2008) and 1 other predicate after a 165-day review. Its family tree reaches back 5 generations to 1980. 15 later devices descend from it.
- Decided
- Apr 29, 2011
- Review
- 165 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K800380 (1980). 15 ancestors in all. 15 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK800380 Fes Orthosis Model NO. 2000Empi · 1980
- 4 generations backK974514 External Functional Neuromuscular StimulatorNeuromotion, Inc. · 1998
- 3 generations backK050991 The Odfs Dropped Foot StimulatorDepartment of Medical Physics and Biomedical Eng. · 2005
- 2 generations backK053468 NESS L300Ness-Neuromuscular Electrical Stimulation Systems · 2006
- 1 generation backK080219 Modification to:Ness L300Ness-Neuromuscular Electrical Stimulation Systems · 2008
- This deviceK103343 L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right…Bioness, Inc. · 2011
- 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 · 9 of its ownK162407 L300 Go SystemBioness, Inc. · 2017
- Descendant · 2 generations on · 7 of its ownK173682 L300 Go SystemBioness, Inc. · 2018
- Descendant · 3 generations on · 5 of its ownK190285 L300 Go SystemBioness, Inc. · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K123972Walkaide SystemInnovative Neurotronics, Inc. · 2013 · cites it directly14descendants
- K140886Walkaide SystemInnovative Neurotronics, Inc. · 2014 · 2 generations on10descendants
- K162407L300 Go SystemBioness, Inc. · 2017 · cites it directly9descendants
- K173682L300 Go SystemBioness, Inc. · 2018 · 2 generations on7descendants
- K190285L300 Go SystemBioness, Inc. · 2019 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K800380 | Fes Orthosis Model NO. 2000 | Empi | 1980 | — |
| −4 | K974514 | External Functional Neuromuscular Stimulator | Neuromotion, Inc. | 1998 | — |
| −3 | K050991 | The Odfs Dropped Foot Stimulator | Department of Medical Physics and Biomedical Eng. | 2005 | — |
| −2 | K053468 | NESS L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2006 | — |
| −1 | K080219 | Modification to:Ness L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2008 | — |
| 0 (this device) | K103343 | L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left) | Bioness, Inc. | 2011 | — |
| +1 | K123972 | Walkaide System | Innovative Neurotronics, Inc. | 2013 | — |
| +2 | K140886 | Walkaide System | Innovative Neurotronics, Inc. | 2014 | — |
| +1 | K162407 | L300 Go System | Bioness, Inc. | 2017 | — |
| +2 | K173682 | L300 Go System | Bioness, Inc. | 2018 | — |
| +3 | K190285 | L300 Go System | Bioness, Inc. | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K080219 | Modification to:Ness L300Summary page 3…wered muscle stimulators Predicate devices: 1) Company: N.E.S.S (Neuromuscular Electrical Stimulation Systems) Ltd. Device: NESS L300 (K080219) 2) Company: N.E.S.S (Neuromuscular Electrical Stimulation Systems) Ltd. Device: ,NESS system (K022… | 2008 |
| * | K022776 | Ness SystemSummary page 3…Device: NESS L300 (K080219) 2) Company: N.E.S.S (Neuromuscular Electrical Stimulation Systems) Ltd. Device: ,NESS system (K022776) Purpose of the traditional 510(k) notice: The NESS L300 Plus is a new device based on the NESS L300 and on the NESS… | 2002 |
What descends from it? (15)
See all 153 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)
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 31 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K123972 (Innovative Neurotronics, Inc., 2013) has gone furthest, with 14 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. 2011, 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 Plus System is intended to Provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease. During gait, the L300 Plus System electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot and knee flexion or extension, thus it may improve the individual's gait. The L300 Plus System may also:
* Facilitate Muscle re-education
* Prevent/retard disuse atrophy
* Maintain or increase joint range of motion
* Increase local blood flow
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103343: L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103343
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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