510(k) · Cleared
ClearedNess L300 System Kit, Lef Model LG3-5100; Ness L300 System Kit, Right Model LG3-5000; Small Ness L300 System Kit, Right
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 Dec 27, 2012 as substantially equivalent to K120853 (Bioness, Inc., 2012) and 1 other predicate after a 107-day review. Its family tree reaches back 3 generations to 1980. 10 later devices descend from it.
- Decided
- Dec 27, 2012
- Review
- 107 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K800380 (1980). 7 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK800380 Fes Orthosis Model NO. 2000Empi · 1980
- 2 generations backK974514 External Functional Neuromuscular StimulatorNeuromotion, Inc. · 1998
- 1 generation backK052329 Walkaide System, Models 20-0100, 20-0310, 20-1000Innovative Neurotronics, Inc. · 2005 · Recalled
- This deviceK122784 Ness L300 System Kit, Lef Model LG3-5100; Ness L300 System Kit…Bioness, Inc. · 2012
- 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
- Descendant · 4 generations on · 2 of its ownK213622 Cionic Neural Sleeve NS-100Cionic · 2022
- Descendant · 5 generations on · 1 of its ownK221823 Cionic Neural Sleeve NS-100Cionic · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K162407L300 Go SystemBioness, Inc. · 2017 · cites it directly9descendants
- K173682L300 Go SystemBioness, Inc. · 2018 · 2 generations on7descendants
- K190285L300 Go SystemBioness, Inc. · 2019 · 3 generations on5descendants
- K213622Cionic Neural Sleeve NS-100Cionic · 2022 · 4 generations on2descendants
- K221823Cionic Neural Sleeve NS-100Cionic · 2022 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K800380 | Fes Orthosis Model NO. 2000 | Empi | 1980 | — |
| −2 | K974514 | External Functional Neuromuscular Stimulator | Neuromotion, Inc. | 1998 | — |
| −1 | K052329 | Walkaide System, Models 20-0100, 20-0310, 20-1000 | Innovative Neurotronics, Inc. | 2005 | 1 |
| 0 (this device) | K122784 | Ness L300 System Kit, Lef Model LG3-5100; Ness L300 System Kit, Right Model… | Bioness, Inc. | 2012 | — |
| +1 | K162407 | L300 Go System | Bioness, Inc. | 2017 | — |
| +2 | K173682 | L300 Go System | Bioness, Inc. | 2018 | — |
| +3 | K190285 | L300 Go System | Bioness, Inc. | 2019 | — |
| +4 | K213622 | Cionic Neural Sleeve NS-100 | Cionic | 2022 | — |
| +5 | K221823 | Cionic Neural Sleeve NS-100 | Cionic | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 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 |
|---|---|---|---|
| * | K120853 | Ness L300 System Kit, Left, Ness L300 System Kit, Right, Small Ness L300 System Kit…Summary page 1…1. NESS (Neuromuscular Electrical Stimulation Systems) Ltd. (currently known as Bioness Neuromodulation Ltd., a Bioness Inc. Company) NESS L300 System (K1 20853, SE 4.20.2012) 2. Innovative Neurotronics Walkaide System (K052329, SE 9.21.2005) Bioness… | 2012 |
| * | K052329 | Walkaide System, Models 20-0100, 20-0310, 20-1000Summary page 1…known as Bioness Neuromodulation Ltd., a Bioness Inc. Company) NESS L300 System (K1 20853, SE 4.20.2012) 2. Innovative Neurotronics Walkaide System (K052329, SE 9.21.2005) Bioness 50k Scin… | 2005 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162407 | L300 Go System | 2017 | 9 |
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 32 years and passes through 4 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K162407 (Bioness, Inc., 2017) has gone furthest, with 9 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. 2012, 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 Foot Drop System is intended to provide ankle dorsiflexion
in individuals (adults and pediatrics) who have foot drop 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.
The NESS L300 may improve gait, facilitate muscle re-education, prevent or retard
disuse 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/K122784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122784: Ness L300 System Kit, Lef Model LG3-5100; Ness L300 System Kit, Right Model LG3-5000; Small Ness L300 System Kit, Right.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122784
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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