510(k) · Cleared
ClearedMentamove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cole & Associates · IPF Stimulator, Muscle, Powered
Cleared on Oct 1, 2004 as substantially equivalent to K012885 (Dan Med, Inc., 2001) after a 183-day review. Its family tree reaches back 1 generation to 2001. 38 later devices descend from it.
- Decided
- Oct 1, 2004
- Review
- 183 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012885 (2001). 38 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK012885 Neuromove NM900Dan Med, Inc. · 2001
- This deviceK040849 MentamoveCole & Associates · 2004
- Descendant · cites it directly · 34 of its ownK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- Descendant · 2 generations on · 21 of its ownK110179 IncontrolIncontrol Medical, LLC · 2012
- Descendant · 3 generations on · 10 of its ownK134020 IntonemvIncontrol Medical, LLC · 2014
- Descendant · 3 generations on · 9 of its ownK141158 APEXIncontrol Medical, LLC · 2014
- Descendant · 4 generations on · 6 of its ownK181497 HPM-6000UFBTL Industries, Inc. · 2018
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K080950Stiwell MED4Otto Bock, Austria GmbH · 2009 · cites it directly34descendants
- K110179IncontrolIncontrol Medical, LLC · 2012 · 2 generations on21descendants
- K134020IntonemvIncontrol Medical, LLC · 2014 · 3 generations on10descendants
- K141158APEXIncontrol Medical, LLC · 2014 · 3 generations on9descendants
- K181497HPM-6000UFBTL Industries, Inc. · 2018 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012885 | Neuromove NM900 | Dan Med, Inc. | 2001 | — |
| 0 (this device) | K040849 | Mentamove | Cole & Associates | 2004 | — |
| +1 | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| +2 | K110179 | Incontrol | Incontrol Medical, LLC | 2012 | — |
| +3 | K134020 | Intonemv | Incontrol Medical, LLC | 2014 | — |
| +3 | K141158 | APEX | Incontrol Medical, LLC | 2014 | — |
| +4 | K181497 | HPM-6000UF | BTL Industries, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2017 | 1 | 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), 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 |
|---|---|---|---|
| * | K012885 | Neuromove NM900 | 2001 |
What descends from it? (38)
See all 382 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?
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?
Mentamove is indicated for use in the rehabilitation of victims of stroke. It utilizes stroke victims' electromyographic signals to guide the application of electrical muscle stimulation. This stimulation helps stroke victims to relearn voluntary motor functions of the extremities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040849: Mentamove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040849
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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