510(k) · Cleared
ClearedMyndMove 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myndtec, Inc. · GZI Stimulator, Neuromuscular, External Functional
Cleared on Mar 3, 2022 as substantially equivalent to K170564 (Myndtec, Inc., 2017) after a 237-day review. Its family tree reaches back 3 generations to 2011. 1 later device descends from it.
- Decided
- Mar 3, 2022
- Review
- 237 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K111767 (2011). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK111767 Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican…Ness-Neuromuscular Electrical Stimulation Systems · 2011
- 2 generations backK123636 H200 Wireless Hand Rehabilitation System with Optional…Bioness, Inc. · 2013
- 1 generation backK170564 MyndMove System, MyndMove Functional Electrical StimulatorMyndtec, Inc. · 2017
- This deviceK212149 MyndMove 2.0Myndtec, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK233006 MyndMove, MyndMove 2.0Myndtec, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K233006MyndMove, MyndMove 2.0Myndtec, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K111767 | Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican Kit | Ness-Neuromuscular Electrical Stimulation Systems | 2011 | — |
| −2 | K123636 | H200 Wireless Hand Rehabilitation System with Optional Intelli-Connect… | Bioness, Inc. | 2013 | — |
| −1 | K170564 | MyndMove System, MyndMove Functional Electrical Stimulator | Myndtec, Inc. | 2017 | — |
| 0 (this device) | K212149 | MyndMove 2.0 | Myndtec, Inc. | 2022 | — |
| +1 | K233006 | MyndMove, MyndMove 2.0 | Myndtec, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K170564 | MyndMove System, MyndMove Functional Electrical StimulatorSummary page 4…Device Identification of Predicate Device Device Applicant 510(k) No. Date Cleared MyndMove MyndTec Inc. K170564 August 30, 2017 Device Description The purpose of this Traditional 510(k) is to obtain clearance for MyndMove 2.0, a… | 2017 |
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 |
|---|---|---|---|
| K233006 | MyndMove, MyndMove 2.0 | 2024 | 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 11 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K233006 (Myndtec, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K170564.
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?
MYNDMOVE 2.0 is an electrical stimulation device indicated for the following uses: Functional Electrical Stimulation (FES) Improvement of arm and hand functions and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury. NeuroMuscular Electrical Stimulation (NMES) • Maintenance and/or increase of arm and hand range of motion • Prevention and/or retardation of disuse atrophy • Increase in…
Read the full statement (107 words)
MYNDMOVE 2.0 is an electrical stimulation device indicated for the following uses:
Functional Electrical Stimulation (FES)
Improvement of arm and hand functions and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury.
NeuroMuscular Electrical Stimulation (NMES)
• Maintenance and/or increase of arm and hand range of motion
• Prevention and/or retardation of disuse atrophy
• Increase in local blood circulation
• Reduction of muscle spasm
• Re-education of muscles.
MyndMove therapy can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212149: MyndMove 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212149
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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