510(k) · Cleared
ClearedNerve and Muscle Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Xft Medical Limited · GZI Stimulator, Neuromuscular, External Functional
Cleared on Sep 23, 2020 as substantially equivalent to K162718 (Shenzhen Xft Medical Limited, 2017) after a 302-day review. Its family tree reaches back 8 generations to 1980.
- Decided
- Sep 23, 2020
- Review
- 302 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K800380 (1980). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK800380 Fes Orthosis Model NO. 2000Empi · 1980
- 7 generations backK974514 External Functional Neuromuscular StimulatorNeuromotion, Inc. · 1998
- 6 generations backK050991 The Odfs Dropped Foot StimulatorDepartment of Medical Physics and Biomedical Eng. · 2005
- 5 generations backK053468 NESS L300Ness-Neuromuscular Electrical Stimulation Systems · 2006
- 4 generations backK080219 Modification to:Ness L300Ness-Neuromuscular Electrical Stimulation Systems · 2008
- 3 generations backK103343 L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right…Bioness, Inc. · 2011
- 2 generations backK123972 Walkaide SystemInnovative Neurotronics, Inc. · 2013
- 1 generation backK162718 Foot Drop System (Model XFT-2001D)Shenzhen Xft Medical Limited · 2017
- This deviceK193276 Nerve and Muscle StimulatorShenzhen Xft Medical Limited · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K800380 | Fes Orthosis Model NO. 2000 | Empi | 1980 | — |
| −7 | K974514 | External Functional Neuromuscular Stimulator | Neuromotion, Inc. | 1998 | — |
| −6 | K050991 | The Odfs Dropped Foot Stimulator | Department of Medical Physics and Biomedical Eng. | 2005 | — |
| −5 | K053468 | NESS L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2006 | — |
| −4 | 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 | — |
| −1 | K162718 | Foot Drop System (Model XFT-2001D) | Shenzhen Xft Medical Limited | 2017 | — |
| 0 (this device) | K193276 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | 2020 | — |
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 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 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? (1)
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 |
|---|---|---|---|
| * | K162718 | Foot Drop System (Model XFT-2001D)Summary page 5…Predicate Device Manufacturer Shenzhen XFT Medical Limited Trade name Foot Drop System Model XFT-2001D 510(K) Number: K162718 Product Code GZI 4. Device Description Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) is a wearable and D… | 2017 |
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 40 years and passes through 7 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 20 ancestors has a recall of any class.
How does its category compare?
All GZI devicesGZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) 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 walking, the Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle reeducation, and maintained or increased joint range of motion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193276: Nerve and Muscle Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193276
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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