510(k) · Cleared
ClearedCionic Neural Sleeve NS-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cionic · GZI Stimulator, Neuromuscular, External Functional
Cleared on Jul 21, 2022 as substantially equivalent to K213622 (Cionic, 2022) after a 28-day review. Its family tree reaches back 12 generations to 1980. 1 later device descends from it.
- Decided
- Jul 21, 2022
- Review
- 28 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K800380 (1980). 26 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK800380 Fes Orthosis Model NO. 2000Empi · 1980
- 8 generations between
- 3 generations backK173682 L300 Go SystemBioness, Inc. · 2018
- 2 generations backK190285 L300 Go SystemBioness, Inc. · 2019
- 1 generation backK213622 Cionic Neural Sleeve NS-100Cionic · 2022
- This deviceK221823 Cionic Neural Sleeve NS-100Cionic · 2022
- Descendant · cites it directly · 0 of its ownK243828 Cionic Neural Sleeve (NS-200)Cionic, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK800380 Fes Orthosis Model NO. 2000Empi · 1980
- 11 generations backK974514 External Functional Neuromuscular StimulatorNeuromotion, Inc. · 1998
- 10 generations backK050991 The Odfs Dropped Foot StimulatorDepartment of Medical Physics and Biomedical Eng. · 2005
- 9 generations backK053468 NESS L300Ness-Neuromuscular Electrical Stimulation Systems · 2006
- 8 generations backK080219 Modification to:Ness L300Ness-Neuromuscular Electrical Stimulation Systems · 2008
- 7 generations backK103343 L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right…Bioness, Inc. · 2011
- 6 generations backK123972 Walkaide SystemInnovative Neurotronics, Inc. · 2013
- 5 generations backK140886 Walkaide SystemInnovative Neurotronics, Inc. · 2014
- 4 generations backK162407 L300 Go SystemBioness, Inc. · 2017
- 3 generations backK173682 L300 Go SystemBioness, Inc. · 2018
- 2 generations backK190285 L300 Go SystemBioness, Inc. · 2019
- 1 generation backK213622 Cionic Neural Sleeve NS-100Cionic · 2022
- This deviceK221823 Cionic Neural Sleeve NS-100Cionic · 2022
Most influential descendants
Showing 1 of 1 · See all- K243828Cionic Neural Sleeve (NS-200)Cionic, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K800380 | Fes Orthosis Model NO. 2000 | Empi | 1980 | — |
| −11 | K974514 | External Functional Neuromuscular Stimulator | Neuromotion, Inc. | 1998 | — |
| −10 | K050991 | The Odfs Dropped Foot Stimulator | Department of Medical Physics and Biomedical Eng. | 2005 | — |
| −9 | K053468 | NESS L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2006 | — |
| −8 | K080219 | Modification to:Ness L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2008 | — |
| −7 | K103343 | L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left) | Bioness, Inc. | 2011 | — |
| −6 | K123972 | Walkaide System | Innovative Neurotronics, Inc. | 2013 | — |
| −5 | K140886 | Walkaide System | Innovative Neurotronics, Inc. | 2014 | — |
| −4 | K162407 | L300 Go System | Bioness, Inc. | 2017 | — |
| −3 | K173682 | L300 Go System | Bioness, Inc. | 2018 | — |
| −2 | K190285 | L300 Go System | Bioness, Inc. | 2019 | — |
| −1 | K213622 | Cionic Neural Sleeve NS-100 | Cionic | 2022 | — |
| 0 (this device) | K221823 | Cionic Neural Sleeve NS-100 | Cionic | 2022 | — |
| +1 | K243828 | Cionic Neural Sleeve (NS-200) | Cionic, Inc. | 2025 | — |
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 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K213622 | Cionic Neural Sleeve NS-100Summary page 5…nic Neural Sleeve to support the Android operating system. Other design changes which are considered minor have been implemented to the subject device since the original K213622 clearance. These changes are minor software updates which were implemented to improve the application’s overall stability and per… | 2022 |
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 |
|---|---|---|---|
| K243828 | Cionic Neural Sleeve (NS-200) | 2025 | 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 42 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K243828 (Cionic, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GZI devicesGZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Cionic Neural Sleeve NS-100 is intended to provide ankle dorsiflexion and/or plantarflexion in adult individuals with foot drop and/or 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 Cionic Neural Sleeve NS-100 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion of…
Read the full statement (110 words)
The Cionic Neural Sleeve NS-100 is intended to provide ankle dorsiflexion and/or plantarflexion in adult individuals with
foot drop and/or 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 Cionic Neural Sleeve NS-100 electrically
stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion of the foot and/or knee flexion or
extension; thus, it also may improve the individual's gait.
The Cionic Neural Sleeve NS-100 may also:
- Facilitate muscle re-education
- Prevent/retard disuse atrophy
- Maintain or increase joint range of motion
- Increase local blood flow
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/K221823 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221823: Cionic Neural Sleeve NS-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221823
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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