510(k) · Cleared
ClearedHandmaster
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuromusclar Electrical Stimulation Systems, Ltd. · GZI Stimulator, Neuromuscular, External Functional
Cleared on Jun 15, 2001 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 37 later devices descend from it.
- Decided
- Jun 15, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 0
37 later devices descend from it, 2 citing it directly.
- This deviceK010837 HandmasterNeuromusclar Electrical Stimulation Systems, Ltd. · 2001
- Descendant · cites it directly · 35 of its ownK031900 HandmasterNess-Neuromuscular Electrical Stimulation Systems · 2003
- Descendant · 2 generations on · 34 of its ownK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- Descendant · 3 generations on · 21 of its ownK110179 IncontrolIncontrol Medical, LLC · 2012
- Descendant · 4 generations on · 10 of its ownK134020 IntonemvIncontrol Medical, LLC · 2014
- Descendant · 4 generations on · 9 of its ownK141158 APEXIncontrol Medical, LLC · 2014
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K031900HandmasterNess-Neuromuscular Electrical Stimulation Systems · 2003 · cites it directly35descendants
- K080950Stiwell MED4Otto Bock, Austria GmbH · 2009 · 2 generations on34descendants
- K110179IncontrolIncontrol Medical, LLC · 2012 · 3 generations on21descendants
- K134020IntonemvIncontrol Medical, LLC · 2014 · 4 generations on10descendants
- K141158APEXIncontrol Medical, LLC · 2014 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010837 | Handmaster | Neuromusclar Electrical Stimulation Systems, Ltd. | 2001 | — |
| +1 | K031900 | Handmaster | Ness-Neuromuscular Electrical Stimulation Systems | 2003 | — |
| +2 | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| +3 | K110179 | Incontrol | Incontrol Medical, LLC | 2012 | — |
| +4 | K134020 | Intonemv | Incontrol Medical, LLC | 2014 | — |
| +4 | K141158 | APEX | Incontrol Medical, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (37)
See all 372 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?
- Of its descendants, K031900 (Ness-Neuromuscular Electrical Stimulation Systems, 2003) has gone furthest, with 35 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.
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 | — |
https://510kreport.com/device/K010837 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010837: Handmaster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010837
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026