510(k) · Cleared
ClearedThe Odfs Dropped Foot Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Department of Medical Physics and Biomedical Eng. · GZI Stimulator, Neuromuscular, External Functional
Cleared on Jul 15, 2005 as substantially equivalent to K951951 (Empi, 1996) and 1 other predicate after an 87-day review. Its family tree reaches back 2 generations to 1980. 20 later devices descend from it.
- Decided
- Jul 15, 2005
- Review
- 87 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K800380 (1980). 6 ancestors in all. 20 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK800380 Fes Orthosis Model NO. 2000Empi · 1980
- 1 generation backK974514 External Functional Neuromuscular StimulatorNeuromotion, Inc. · 1998
- This deviceK050991 The Odfs Dropped Foot StimulatorDepartment of Medical Physics and Biomedical Eng. · 2005
- Descendant · cites it directly · 17 of its ownK053468 NESS L300Ness-Neuromuscular Electrical Stimulation Systems · 2006
- Descendant · cites it directly · 16 of its ownK102115 Odfs PaceOdstock Medical, Ltd. · 2011
- Descendant · 2 generations on · 16 of its ownK080219 Modification to:Ness L300Ness-Neuromuscular Electrical Stimulation Systems · 2008
- Descendant · 3 generations on · 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
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K053468NESS L300Ness-Neuromuscular Electrical Stimulation Systems · 2006 · cites it directly17descendants
- K102115Odfs PaceOdstock Medical, Ltd. · 2011 · cites it directly16descendants
- K080219Modification to:Ness L300Ness-Neuromuscular Electrical Stimulation Systems · 2008 · 2 generations on16descendants
- K103343L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left)Bioness, Inc. · 2011 · 3 generations on15descendants
- K123972Walkaide SystemInnovative Neurotronics, Inc. · 2013 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K800380 | Fes Orthosis Model NO. 2000 | Empi | 1980 | — |
| −1 | K974514 | External Functional Neuromuscular Stimulator | Neuromotion, Inc. | 1998 | — |
| 0 (this device) | K050991 | The Odfs Dropped Foot Stimulator | Department of Medical Physics and Biomedical Eng. | 2005 | — |
| +1 | K053468 | NESS L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2006 | — |
| +1 | K102115 | Odfs Pace | Odstock Medical, Ltd. | 2011 | — |
| +2 | K080219 | Modification to:Ness L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2008 | — |
| +3 | K103343 | L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left) | Bioness, Inc. | 2011 | — |
| +2 | K123972 | Walkaide System | Innovative Neurotronics, Inc. | 2013 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K951951 | Focus Model 795 UnitSummary page 2…3. PREDICATE DEVICES Predicate Name Company K Number EMPI Focus Model 795 EMPI K951951 WalkAide NeuroMotion K974514 4. DEVICE DESCRIPTION The ODFS Dropped… | 1996 |
| * | K974514 | External Functional Neuromuscular StimulatorSummary page 2…any K Number EMPI Focus Model 795 EMPI K951951 WalkAide NeuroMotion K974514 4. DEVICE DESCRIPTION The ODFS Dropped Foot Stimulator (ODFSIII Version 6.2) is an external functional n… | 1998 |
What descends from it? (20)
See all 203 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 25 years and passes through 3 companies; a new generation was cleared every 17.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K053468 (Ness-Neuromuscular Electrical Stimulation Systems, 2006) has gone furthest, with 17 descendants of its own.
- 5 other devices also cite its predicate K951951.
How does its category compare?
All GZI devicesGZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ODFS Dropped Foot Stimulator is intended to provide ankle dorsiflexion in individuals with dropped foot following an upper motor neuron injury. During the swing phase of gait, the ODFS electrically stimulates muscles in the leg and ankle of partially paralyzed individuals to provide flexion of the foot and may thus improve the individual's gait. Additional benefits of Functional Electrical Stimulation (FES) may include muscle re-education…
Read the full statement (111 words)
The ODFS Dropped Foot Stimulator is intended to provide ankle dorsiflexion in individuals with dropped foot following an upper motor neuron injury. During the swing phase of gait, the ODFS electrically stimulates muscles in the leg and ankle of partially paralyzed individuals to provide flexion of the foot and may thus improve the individual's gait. Additional benefits of Functional Electrical Stimulation (FES) may include muscle re-education, prevention/retardation of disuse atrophy, maintained or increased joint range of motion, and increased local blood flow.
The ODFS is a medical device and should only be used under medical supervision for adjunctive therapy for the treatment of dropped foot following an upper motor neuron injury.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050991 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050991: The Odfs Dropped Foot Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050991
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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