510(k) · Cleared
ClearedMygait Stimulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otto Bock Healthcare Products GmbH · GZI Stimulator, Neuromuscular, External Functional
Cleared on Apr 2, 2015 as substantially equivalent to K123972 (Innovative Neurotronics, Inc., 2013) and 2 other predicates after a 269-day review. Its family tree reaches back 7 generations to 1980. 1 later device descends from it.
- Decided
- Apr 2, 2015
- Review
- 269 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K800380 (1980). 22 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK800380 Fes Orthosis Model NO. 2000Empi · 1980
- 6 generations backK974514 External Functional Neuromuscular StimulatorNeuromotion, Inc. · 1998
- 5 generations backK050991 The Odfs Dropped Foot StimulatorDepartment of Medical Physics and Biomedical Eng. · 2005
- 4 generations backK053468 NESS L300Ness-Neuromuscular Electrical Stimulation Systems · 2006
- 3 generations backK080219 Modification to:Ness L300Ness-Neuromuscular Electrical Stimulation Systems · 2008
- 2 generations backK103343 L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right…Bioness, Inc. · 2011
- 1 generation backK123972 Walkaide SystemInnovative Neurotronics, Inc. · 2013
- This deviceK141812 Mygait Stimulation SystemOtto Bock Healthcare Products GmbH · 2015
- Descendant · cites it directly · 0 of its ownK202110 MStim Drop Model: LGT-233Guangzhou Longest Science & Technology Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K202110MStim Drop Model: LGT-233Guangzhou Longest Science & Technology Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K800380 | Fes Orthosis Model NO. 2000 | Empi | 1980 | — |
| −6 | K974514 | External Functional Neuromuscular Stimulator | Neuromotion, Inc. | 1998 | — |
| −5 | K050991 | The Odfs Dropped Foot Stimulator | Department of Medical Physics and Biomedical Eng. | 2005 | — |
| −4 | K053468 | NESS L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2006 | — |
| −3 | K080219 | Modification to:Ness L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2008 | — |
| −2 | K103343 | L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left) | Bioness, Inc. | 2011 | — |
| −1 | K123972 | Walkaide System | Innovative Neurotronics, Inc. | 2013 | — |
| 0 (this device) | K141812 | Mygait Stimulation System | Otto Bock Healthcare Products GmbH | 2015 | — |
| +1 | K202110 | MStim Drop Model: LGT-233 | Guangzhou Longest Science & Technology Co., Ltd. | 2021 | — |
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 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (3)
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 |
|---|---|---|---|
| * | K123972 | Walkaide SystemSummary page 5…redicate Devices Name: Walkaide Manufacturer: Innovative Neurotronics, Inc. 510k Number: K123972 Date Cleared: April 4th, 2013 Name: Empi 300pv Manufacturer:… | 2013 |
| * | K021100 | 300 PV Complete Electrotherapy SystemSummary page 5…leared: April 4th, 2013 Name: Empi 300pv Manufacturer: Empi, Inc 510k Number: K021100 Date Cleared: June 18th, 2002 Name: NESS L300 Plus System* Manuf… | 2002 |
| * | K103343 | L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left)Summary page 5…2002 Name: NESS L300 Plus System* Manufacturer: Bioness Neuromodulation Ltd. 510k Number: K103343 Date Cleared: April 29th, 2011 * Primary predicate Qualitätsmanagement Otto Bock Healthcare P… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202110 | MStim Drop Model: LGT-233 | 2021 | 0 |
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 35 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K202110 (Guangzhou Longest Science & Technology Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K123972.
How does its category compare?
All GZI devicesGZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 stimulation 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 stimulation system sends electric stimuli to muscles in the affected leg, initiating dorsiflexion of the foot and knee extension or flexion and may thus improve the individual's gait. The stimulation system may also prevent or retard atrophy caused by inactivity, facilitate muscle reeducation, maintain or improve the range of motion in the joints and promote local blood circulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141812: Mygait Stimulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141812
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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