510(k) · Cleared
ClearedElectro Neuromuscular Stimulator, Model NMS-Digital
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Life Systems, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Sep 28, 2001 after a 199-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Sep 28, 2001
- Review
- 199 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK010749 Electro Neuromuscular Stimulator, Model NMS-DigitalBiomedical Life Systems, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK081835 Acticare IC and TseBioinduction Limited · 2009
- Descendant · 2 generations on · 2 of its ownK161091 STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK252712 STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK213802 StimOnTM Pain Relief System (GM2439)Gimer Medical Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK063135 Sonic-StimNaimco, Inc. · 2007
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K081835Acticare IC and TseBioinduction Limited · 2009 · cites it directly3descendants
- K161091STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017 · 2 generations on2descendants
- K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc. · 2026 · 3 generations on0descendants
- K213802StimOnTM Pain Relief System (GM2439)Gimer Medical Co., Ltd. · 2022 · 2 generations on0descendants
- K063135Sonic-StimNaimco, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010749 | Electro Neuromuscular Stimulator, Model NMS-Digital | Biomedical Life Systems, Inc. | 2001 | — |
| +1 | K081835 | Acticare IC and Tse | Bioinduction Limited | 2009 | — |
| +2 | K161091 | STIMPOD NMS460 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2017 | — |
| +3 | K252712 | STIMPOD NMS460 Nerve Stimulator | Algiamed Technologies USA, Inc. | 2026 | — |
| +2 | K213802 | StimOnTM Pain Relief System (GM2439) | Gimer Medical Co., Ltd. | 2022 | — |
| +1 | K063135 | Sonic-Stim | Naimco, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 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 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 19.6 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
4 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, K081835 (Bioinduction Limited, 2009) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K010749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010749: Electro Neuromuscular Stimulator, Model NMS-Digital.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010749
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026