510(k) · Cleared
ClearedElpha, Models II 500, II 1000, II 2000, II 3000 and E80
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Danmeter A/S · IPF Stimulator, Muscle, Powered
Cleared on Aug 9, 2004 after a 322-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 40 later devices descend from it.
- Decided
- Aug 9, 2004
- Review
- 322 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 3 citing it directly.
- This deviceK032954 Elpha, Models II 500, II 1000, II 2000, II 3000 and E80Danmeter A/S · 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 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K032954 | Elpha, Models II 500, II 1000, II 2000, II 3000 and E80 | Danmeter A/S | 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 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 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 510(k) statement (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 19.6 · 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (40)
See all 403 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, K080950 (Otto Bock, Austria GmbH, 2009) has gone furthest, with 34 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 | — |
What is it indicated for?
ELPHA 11 500, ELPHA 11 1000 This Danmeter device is designed for the symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post traumatic acute pain. ELPHA 11 2000 This Danmeter device is designed for the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical…
Read the full statement (146 words)
ELPHA 11 500, ELPHA 11 1000
This Danmeter device is designed for the symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
ELPHA 11 2000
This Danmeter device is designed for the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion.
ELPHA 11 3000
This Danmeter device is designed for:
Symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
Relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032954: Elpha, Models II 500, II 1000, II 2000, II 3000 and E80.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032954
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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