510(k) · Cleared

Cleared

External Functional Neuromuscular Stimulator

K974514510(k) TraditionalCleared Feb 6, 199867-day reviewClass II21 CFR 882.5810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Neuromotion, Inc. · GZI Stimulator, Neuromuscular, External Functional

Cleared on Feb 6, 1998 as substantially equivalent to K920436 (Medtronic Vascular, 1992) and 3 other predicates after a 67-day review. Its family tree reaches back 1 generation to 1980. 23 later devices descend from it.

Decided: Feb 6, 1998
Review: 67 days
Class: Class II
Product code: GZI
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K800380 (1980). 4 ancestors in all. 23 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK800380 Fes Orthosis Model NO. 2000Empi · 1980
This deviceK974514 External Functional Neuromuscular StimulatorNeuromotion, Inc. · 1998
Descendant · cites it directly · 20 of its ownK050991 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 · 2 generations on · 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 · cites it directly · 16 of its ownK052329 Walkaide System, Models 20-0100, 20-0310, 20-1000Innovative Neurotronics, Inc. · 2005 · Recalled

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2005high 2 (2005) · low 0 (2007)2026

Most influential descendants

Showing 5 of 23 · See all

K050991The Odfs Dropped Foot StimulatorDepartment of Medical Physics and Biomedical Eng. · 2005 · cites it directly20descendants
K053468NESS L300Ness-Neuromuscular Electrical Stimulation Systems · 2006 · cites it directly17descendants
K102115Odfs PaceOdstock Medical, Ltd. · 2011 · 2 generations on16descendants
K080219Modification to:Ness L300Ness-Neuromuscular Electrical Stimulation Systems · 2008 · 2 generations on16descendants
K052329Walkaide System, Models 20-0100, 20-0310, 20-1000Innovative Neurotronics, Inc. · 2005 · cites it directly16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K800380	Fes Orthosis Model NO. 2000	Empi	1980	—
0 (this device)	K974514	External Functional Neuromuscular Stimulator	Neuromotion, Inc.	1998	—
+1	K050991	The Odfs Dropped Foot Stimulator	Department of Medical Physics and Biomedical Eng.	2005	—
+1	K053468	NESS L300	Ness-Neuromuscular Electrical Stimulation Systems	2006	—
+2	K102115	Odfs Pace	Odstock Medical, Ltd.	2011	—
+2	K080219	Modification to:Ness L300	Ness-Neuromuscular Electrical Stimulation Systems	2008	—
+1	K052329	Walkaide System, Models 20-0100, 20-0310, 20-1000	Innovative Neurotronics, Inc.	2005	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1991	1	0
1992	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	1	0
2008	1	0
2011	2	0
2012	1	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

FIG. 1 — Lineage of K974514, 1980–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K920436	Medtronic Respond Iii Neuromuscular Stimulator Summary page 1 …euromuscular Stimulator Classification Name - External Functional Neuromuscular Stimulator Classification Code - Class II PREDICATE DEVICES: Medtronic, Inc. Respond III K920436 Medtronic, Inc. Respond Select® K903434C Empi, Inc. Model 2000 K800380A Verite Model 817 VERI/DFS™ K813515 510(K) SUMMARY - WAL…	Medtronic Vascular	1992	—
*	K903434	Select Neuromuscular Stimulators Summary page 1 …me - External Functional Neuromuscular Stimulator Classification Code - Class II PREDICATE DEVICES: Medtronic, Inc. Respond III K920436 Medtronic, Inc. Respond Select® K903434C Empi, Inc. Model 2000 K800380A Verite Model 817 VERI/DFS™ K813515 510(K) SUMMARY - WALKAIDE - K974514 PAGE 1 OF 3 === Page 2 =…	Medtronic Vascular	1991	—
*	K800380	Fes Orthosis Model NO. 2000 Summary page 1 …uscular Stimulator Classification Code - Class II PREDICATE DEVICES: Medtronic, Inc. Respond III K920436 Medtronic, Inc. Respond Select® K903434C Empi, Inc. Model 2000 K800380A Verite Model 817 VERI/DFS™ K813515 510(K) SUMMARY - WALKAIDE - K974514 PAGE 1 OF 3 TG DEVICE DESCRIPTION: The…	Empi	1980	—
*	K813515	Veri/DFS TM #817 Summary page 1 …de - Class II PREDICATE DEVICES: Medtronic, Inc. Respond III K920436 Medtronic, Inc. Respond Select® K903434C Empi, Inc. Model 2000 K800380A Verite Model 817 VERI/DFS™ K813515 510(K) SUMMARY - WALKAIDE - K974514 PAGE 1 OF 3 TG DEVICE DESCRIPTION: The WalkAide is an external functional…	Verite	1982	—

What descends from it? (23)

See all 23

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K050991	The Odfs Dropped Foot Stimulator	Department of Medical Physics and Biomedical Eng.	2005	20
K053468	NESS L300	Ness-Neuromuscular Electrical Stimulation Systems	2006	17
K052329	Walkaide System, Models 20-0100, 20-0310, 20-1000	Innovative Neurotronics, Inc.	2005	16

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?

None of the 4 ancestors has a recall.
Of its descendants, K050991 (Department of Medical Physics and Biomedical Eng., 2005) has gone furthest, with 20 descendants of its own.

How does its category compare?

All GZI devices

GZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GZI

2in 2025

2007high 6 (2011) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZI

110in 2022

2007high 299 (2014) · low 81 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GZI

1in 2008

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GZI

3in 2025

2007high 8 (2009) · low 0 (2013)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 NeuroMotion WalkAide is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient’s gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974514 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974514: External Functional Neuromuscular Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974514

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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