510(k) · Cleared
ClearedHandmaster NMS1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
N.E.S.S. Nuromuscular Electrical Stimulation Syst · IPF Stimulator, Muscle, Powered
Cleared on Sep 30, 1998 as substantially equivalent to K952273 (Neuromusclar Electrical Stimulation Systems, Ltd., 1996) after a 76-day review. Its family tree reaches back 2 generations to 1981. 54 later devices descend from it.
- Decided
- Sep 30, 1998
- Review
- 76 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K813008 (1981). 4 ancestors in all. 54 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK813008 Respond II...Neuromuscular StimulatorMedtronic Vascular · 1981
- 1 generation backK952273 Handmaster NMS1Neuromusclar Electrical Stimulation Systems, Ltd. · 1996
- This deviceK982482 Handmaster NMS1N.E.S.S. Nuromuscular Electrical Stimulation Syst · 1998
- 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 · cites it directly · 17 of its ownK022776 Ness SystemNess-Neuromuscular Electrical Stimulation Systems · 2002
- Descendant · 2 generations on · 15 of its ownK103343 L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right…Bioness, Inc. · 2011
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · 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
- K022776Ness SystemNess-Neuromuscular Electrical Stimulation Systems · 2002 · cites it directly17descendants
- K103343L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left)Bioness, Inc. · 2011 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K813008 | Respond II...Neuromuscular Stimulator | Medtronic Vascular | 1981 | — |
| −1 | K952273 | Handmaster NMS1 | Neuromusclar Electrical Stimulation Systems, Ltd. | 1996 | — |
| 0 (this device) | K982482 | Handmaster NMS1 | N.E.S.S. Nuromuscular Electrical Stimulation Syst | 1998 | — |
| +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 | — |
| +1 | K022776 | Ness System | Ness-Neuromuscular Electrical Stimulation Systems | 2002 | — |
| +2 | K103343 | L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left) | Bioness, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 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 |
|---|---|---|---|
| * | K952273 | Handmaster NMS1Summary page 2…ernal Neuromuscular Stimulator Classification Name Powered Muscle Stimulator Predicate Devices N.E.S.S. Neuromuscular Electrical Stimulation Systems HANDMASTER NMS1 (K952273). Intended Use The HANDMASTER NMSI1 is intended to be used to exercise the lower arm and hand by activating the muscles thereof… | 1996 |
What descends from it? (54)
See all 543 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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 14.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K031900 (Ness-Neuromuscular Electrical Stimulation Systems, 2003) has gone furthest, with 35 descendants of its own.
- 3 other devices also cite its predicate K952273.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 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.
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/K982482 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982482: Handmaster NMS1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982482
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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