510(k) · Cleared
ClearedH200 Wireless Hand Rehabilitation System with Optional Intelli-Connect Earpiece Triggering Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioness, Inc. · GZI Stimulator, Neuromuscular, External Functional
Cleared on May 1, 2013 as substantially equivalent to K111767 (Ness-Neuromuscular Electrical Stimulation Systems, 2011) after a 159-day review. Its family tree reaches back 1 generation to 2011. 5 later devices descend from it.
- Decided
- May 1, 2013
- Review
- 159 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K111767 (2011). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK111767 Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican…Ness-Neuromuscular Electrical Stimulation Systems · 2011
- This deviceK123636 H200 Wireless Hand Rehabilitation System with Optional…Bioness, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK170564 MyndMove System, MyndMove Functional Electrical StimulatorMyndtec, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK212149 MyndMove 2.0Myndtec, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK242704 Synchrony (20-3000)Synapse Biomedical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK240632 Neuvotion NeuStim NN-01Neuvotion, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK233006 MyndMove, MyndMove 2.0Myndtec, Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K170564MyndMove System, MyndMove Functional Electrical StimulatorMyndtec, Inc. · 2017 · cites it directly2descendants
- K212149MyndMove 2.0Myndtec, Inc. · 2022 · 2 generations on1descendant
- K242704Synchrony (20-3000)Synapse Biomedical, Inc. · 2025 · cites it directly0descendants
- K240632Neuvotion NeuStim NN-01Neuvotion, Inc. · 2024 · cites it directly0descendants
- K233006MyndMove, MyndMove 2.0Myndtec, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K111767 | Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican Kit | Ness-Neuromuscular Electrical Stimulation Systems | 2011 | — |
| 0 (this device) | K123636 | H200 Wireless Hand Rehabilitation System with Optional Intelli-Connect… | Bioness, Inc. | 2013 | — |
| +1 | K170564 | MyndMove System, MyndMove Functional Electrical Stimulator | Myndtec, Inc. | 2017 | — |
| +2 | K212149 | MyndMove 2.0 | Myndtec, Inc. | 2022 | — |
| +1 | K242704 | Synchrony (20-3000) | Synapse Biomedical, Inc. | 2025 | — |
| +1 | K240632 | Neuvotion NeuStim NN-01 | Neuvotion, Inc. | 2024 | — |
| +2 | K233006 | MyndMove, MyndMove 2.0 | Myndtec, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K111767 | Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican KitSummary page 1…er 882.58 10 External functional neuromuscular stimulators 890.5850 Powered muscle stimulators Predicate device NESS H200 Wireless Hand Device KI 111767 Purpose: This is a product line extension to add an optional hands-free trigger for functional stimulation of the H200 Wireless S… | 2011 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K170564 (Myndtec, Inc., 2017) has gone furthest, with 2 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. 2013, 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 Wireless System is an electrical stimulation device indicated for the following uses:
*Functional Electrical Stimulation (FES).
o Improvement of hand function and active range of motion in patients with hemniplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.
* NeuroMuscular Electrical Stimulation (NMES).
o Maintenance and/or increase of hand range of motion.
o Prevention and/or retardation of disuse atrophy.
o Increase in local blood circulation.
o Reduction of muscle spasm.
o Re-education of muscles.
The Intelli-Connect is an optional accessory device used exclusively with the H200 Wireless Orthosis through simple jaw movements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123636: H200 Wireless Hand Rehabilitation System with Optional Intelli-Connect Earpiece Triggering Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123636
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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