510(k) · Cleared
ClearedL360 Thigh System
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 Sep 12, 2019 as substantially equivalent to K190285 (Bioness, Inc., 2019) and 1 other predicate after a 90-day review. Its family tree reaches back 11 generations to 1980.
- Decided
- Sep 12, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K800380 (1980). 42 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK800380 Fes Orthosis Model NO. 2000Empi · 1980
- 7 generations between
- 3 generations backK162407 L300 Go SystemBioness, Inc. · 2017
- 2 generations backK173682 L300 Go SystemBioness, Inc. · 2018
- 1 generation backK190285 L300 Go SystemBioness, Inc. · 2019
- This deviceK191587 L360 Thigh SystemBioness, Inc. · 2019
Show all 11 generations
- Root · 11 generations backK800380 Fes Orthosis Model NO. 2000Empi · 1980
- 10 generations backK974514 External Functional Neuromuscular StimulatorNeuromotion, Inc. · 1998
- 9 generations backK050991 The Odfs Dropped Foot StimulatorDepartment of Medical Physics and Biomedical Eng. · 2005
- 8 generations backK053468 NESS L300Ness-Neuromuscular Electrical Stimulation Systems · 2006
- 7 generations backK080219 Modification to:Ness L300Ness-Neuromuscular Electrical Stimulation Systems · 2008
- 6 generations backK103343 L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right…Bioness, Inc. · 2011
- 5 generations backK123972 Walkaide SystemInnovative Neurotronics, Inc. · 2013
- 4 generations backK140886 Walkaide SystemInnovative Neurotronics, Inc. · 2014
- 3 generations backK162407 L300 Go SystemBioness, Inc. · 2017
- 2 generations backK173682 L300 Go SystemBioness, Inc. · 2018
- 1 generation backK190285 L300 Go SystemBioness, Inc. · 2019
- This deviceK191587 L360 Thigh SystemBioness, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K800380 | Fes Orthosis Model NO. 2000 | Empi | 1980 | — |
| −10 | K974514 | External Functional Neuromuscular Stimulator | Neuromotion, Inc. | 1998 | — |
| −9 | K050991 | The Odfs Dropped Foot Stimulator | Department of Medical Physics and Biomedical Eng. | 2005 | — |
| −8 | K053468 | NESS L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2006 | — |
| −7 | K080219 | Modification to:Ness L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2008 | — |
| −6 | K103343 | L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left) | Bioness, Inc. | 2011 | — |
| −5 | K123972 | Walkaide System | Innovative Neurotronics, Inc. | 2013 | — |
| −4 | K140886 | Walkaide System | Innovative Neurotronics, Inc. | 2014 | — |
| −3 | K162407 | L300 Go System | Bioness, Inc. | 2017 | — |
| −2 | K173682 | L300 Go System | Bioness, Inc. | 2018 | — |
| −1 | K190285 | L300 Go System | Bioness, Inc. | 2019 | — |
| 0 (this device) | K191587 | L360 Thigh 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 |
| 1993 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 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? (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 |
|---|---|---|---|
| * | K190285 | L300 Go SystemSummary page 5…510(k) Summary Predicate devices: 1. Company: Bioness Inc. Device: L300 Go System (K190285) 2. Company: Bio-Medical Research, Ltd. Device: Kneehab XP, Type 412/421 (K110350) Purpose of th… | 2019 |
| * | K110350 | Kneehab XPSummary page 5…: Bioness Inc. Device: L300 Go System (K190285) 2. Company: Bio-Medical Research, Ltd. Device: Kneehab XP, Type 412/421 (K110350) Purpose of the traditional 510(k) notice: The L360 Thigh System is the Thigh Standalone configuration of its predicate devic… | 2011 |
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 39 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 42 ancestors has a recall of any class.
- 2 other devices also cite its predicate K190285.
How does its category compare?
All GZI devicesGZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 L360 Thigh System is intended 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 L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual’s gait. The L360 Thigh System may also: • Facilitate muscle re-education • Prevent/retard…
Read the full statement (108 words)
The L360 Thigh System is intended 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 L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual’s gait.
The L360 Thigh System may also:
• Facilitate muscle re-education
• Prevent/retard disuse atrophy
• Maintain or increase joint range of motion
• Increase local blood flow
• Provide early post-surgical quadricep and hamstring strengthening
• Improve post-surgical knee stability secondary to quadricep and hamstring strengthening
• Relax muscle spasms
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191587: L360 Thigh System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191587
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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