510(k) · Cleared
ClearedNess H200 Wireless Hand Rehabilitation System User Kit and Clinican Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ness-Neuromuscular Electrical Stimulation Systems · GZI Stimulator, Neuromuscular, External Functional
Cleared on Sep 15, 2011 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Sep 15, 2011
- Review
- 84 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK111767 Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican…Ness-Neuromuscular Electrical Stimulation Systems · 2011
- Descendant · cites it directly · 5 of its ownK123636 H200 Wireless Hand Rehabilitation System with Optional…Bioness, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK170564 MyndMove System, MyndMove Functional Electrical StimulatorMyndtec, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK212149 MyndMove 2.0Myndtec, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK242704 Synchrony (20-3000)Synapse Biomedical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK240632 Neuvotion NeuStim NN-01Neuvotion, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K123636H200 Wireless Hand Rehabilitation System with Optional Intelli-Connect Earpiece…Bioness, Inc. · 2013 · cites it directly5descendants
- K170564MyndMove System, MyndMove Functional Electrical StimulatorMyndtec, Inc. · 2017 · 2 generations on2descendants
- K212149MyndMove 2.0Myndtec, Inc. · 2022 · 3 generations on1descendant
- K242704Synchrony (20-3000)Synapse Biomedical, Inc. · 2025 · 2 generations on0descendants
- K240632Neuvotion NeuStim NN-01Neuvotion, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K170564 | MyndMove System, MyndMove Functional Electrical Stimulator | Myndtec, Inc. | 2017 | — |
| +3 | K212149 | MyndMove 2.0 | Myndtec, Inc. | 2022 | — |
| +2 | K242704 | Synchrony (20-3000) | Synapse Biomedical, Inc. | 2025 | — |
| +2 | K240632 | Neuvotion NeuStim NN-01 | Neuvotion, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123636 | H200 Wireless Hand Rehabilitation System with Optional Intelli-Connect Earpiece… | 2013 | 5 |
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?
- Of its descendants, K123636 (Bioness, Inc., 2013) has gone furthest, with 5 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. 2011, 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 NESS H200®D Wireless Hand Rehabilitation System 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 05 spinal cord injury
NeuroMuscular Electrical Stimulation (NMES):
- Maintenance and/or increase of range of motion
- Prevention and/or retardation of disuse atrophy
- Increase of local blood circulation
- Reduction of muscle spasm
- Muscle re-education
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111767 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111767: Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111767
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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