510(k) · Cleared
ClearedNeuvotion NeuStim NN-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuvotion, Inc. · GZI Stimulator, Neuromuscular, External Functional
Cleared on Nov 22, 2024 as substantially equivalent to K123636 (Bioness, Inc., 2013) after a 261-day review. Its family tree reaches back 2 generations to 2011.
- Decided
- Nov 22, 2024
- Review
- 261 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K111767 (2011). No later device cites it as a predicate yet.
- Root · 2 generations backK111767 Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican…Ness-Neuromuscular Electrical Stimulation Systems · 2011
- 1 generation backK123636 H200 Wireless Hand Rehabilitation System with Optional…Bioness, Inc. · 2013
- This deviceK240632 Neuvotion NeuStim NN-01Neuvotion, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K111767 | Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican Kit | Ness-Neuromuscular Electrical Stimulation Systems | 2011 | — |
| −1 | K123636 | H200 Wireless Hand Rehabilitation System with Optional Intelli-Connect… | Bioness, Inc. | 2013 | — |
| 0 (this device) | K240632 | Neuvotion NeuStim NN-01 | Neuvotion, Inc. | 2024 | — |
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 |
|---|---|---|---|
| * | K123636 | H200 Wireless Hand Rehabilitation System with Optional Intelli-Connect Earpiece…Summary page 5…imulator, Neuromuscular, External Functional Regulation Number: 882.5810 Product Codes: GZI, IPF Legally Marketed Predicate Devices 21 CFR 807.92(a)(3): K123636, Bioness NESS H200 Wireless Hand Rehabilitation System Product Codes GZI, IPF Device Description Summary 21 CFR 807.92(a)(4… | 2013 |
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 13 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K123636.
How does its category compare?
All GZI devicesGZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 NeuStim NN-01 is an electrical stimulation device indicated for the following uses:
Functional Electrical Stimulation (FES):
Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.
NeuroMuscular Electrical Stimulation (NMES):
• Maintaining or increasing hand range of motion;
• Prevention or retardation of disuse atrophy;
• Increasing local blood circulation;
• Relaxation of muscle spasms; and
• Muscle re-education.
The NeuStim NN-01 is intended for use on the right arm/right hand only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240632 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240632: Neuvotion NeuStim NN-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240632
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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