510(k) · Cleared
ClearedModification to Handmaster
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 Nov 14, 2001 as substantially equivalent to K952273 (Neuromusclar Electrical Stimulation Systems, Ltd., 1996) and 3 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- Nov 14, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K813008 (1981). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK813008 Respond II...Neuromuscular StimulatorMedtronic Vascular · 1981
- 2 generations backK952273 Handmaster NMS1Neuromusclar Electrical Stimulation Systems, Ltd. · 1996
- 1 generation backK982482 Handmaster NMS1N.E.S.S. Nuromuscular Electrical Stimulation Syst · 1998
- This deviceK012823 Modification to HandmasterNess-Neuromuscular Electrical Stimulation Systems · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K813008 | Respond II...Neuromuscular Stimulator | Medtronic Vascular | 1981 | — |
| −2 | K952273 | Handmaster NMS1 | Neuromusclar Electrical Stimulation Systems, Ltd. | 1996 | — |
| −1 | K982482 | Handmaster NMS1 | N.E.S.S. Nuromuscular Electrical Stimulation Syst | 1998 | — |
| 0 (this device) | K012823 | Modification to Handmaster | Ness-Neuromuscular Electrical Stimulation Systems | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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? (4)
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 |
|---|---|---|---|
| * | K952273 | Handmaster NMS1Summary page 1…ion Name: Powered Muscle Stimulator and External Functional Neuromuscular Stimulator Predicate Devices N.E.S.S. Neuromuscular Electrical Stimulation Systems Handmaster (K952273, K982482, and K010837); DanMed, Inc. AM800 Automove Electrical Muscle Stimulator (K972997). 7-3 WDC - 64270/ - #1379228 v! ===… | 1996 |
| * | K982482 | Handmaster NMS1Summary page 1…Powered Muscle Stimulator and External Functional Neuromuscular Stimulator Predicate Devices N.E.S.S. Neuromuscular Electrical Stimulation Systems Handmaster (K952273, K982482, and K010837); DanMed, Inc. AM800 Automove Electrical Muscle Stimulator (K972997). 7-3 WDC - 64270/ - #1379228 v! === Page 2 =… | 1998 |
| * | K010837 | HandmasterSummary page 1…le Stimulator and External Functional Neuromuscular Stimulator Predicate Devices N.E.S.S. Neuromuscular Electrical Stimulation Systems Handmaster (K952273, K982482, and K010837); DanMed, Inc. AM800 Automove Electrical Muscle Stimulator (K972997). 7-3 WDC - 64270/ - #1379228 v! Intended U… | 2001 |
| * | K972997 | AM800 Automove Emg Triggered Electrical Muscle StimulationSummary page 1…cate Devices N.E.S.S. Neuromuscular Electrical Stimulation Systems Handmaster (K952273, K982482, and K010837); DanMed, Inc. AM800 Automove Electrical Muscle Stimulator (K972997). 7-3 WDC - 64270/ - #1379228 v! Intended Use The Handmaster is intended to be used for the following indicati… | 1997 |
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 20 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 7 ancestors has a recall.
- 3 other devices also cite its predicate K952273.
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 | — |
What is it indicated for?
The Handmaster is intended to be used for the following indications:
Maintenance or increase of range of motion, reduction of muscle spasm,
prevention or retardation of disuse atrophy, muscle reeducation, and
increasing local blood circulation. In patients suffering from upper limb
paralysis due to C5 spinal cord injury or hemiplegia due to stroke, it is also
intended to provide hand active range of motion and hand function.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012823 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012823: Modification to Handmaster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012823
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026