510(k) · Cleared
ClearedDynatron 500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynatronics Corp. · IPF Stimulator, Muscle, Powered
Cleared on Aug 18, 1987 after a 162-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 67 later devices descend from it.
- Decided
- Aug 18, 1987
- Review
- 162 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 0
67 later devices descend from it, 2 citing it directly.
- This deviceK870947 Dynatron 500Dynatronics Corp. · 1987
- Descendant · cites it directly · 55 of its ownK952273 Handmaster NMS1Neuromusclar Electrical Stimulation Systems, Ltd. · 1996
- Descendant · 2 generations on · 54 of its ownK982482 Handmaster NMS1N.E.S.S. Nuromuscular Electrical Stimulation Syst · 1998
- Descendant · 2 generations on · 35 of its ownK031900 HandmasterNess-Neuromuscular Electrical Stimulation Systems · 2003
- Descendant · 3 generations on · 34 of its ownK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- Descendant · 4 generations on · 21 of its ownK110179 IncontrolIncontrol Medical, LLC · 2012
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K952273Handmaster NMS1Neuromusclar Electrical Stimulation Systems, Ltd. · 1996 · cites it directly55descendants
- K982482Handmaster NMS1N.E.S.S. Nuromuscular Electrical Stimulation Syst · 1998 · 2 generations on54descendants
- K031900HandmasterNess-Neuromuscular Electrical Stimulation Systems · 2003 · 2 generations on35descendants
- K080950Stiwell MED4Otto Bock, Austria GmbH · 2009 · 3 generations on34descendants
- K110179IncontrolIncontrol Medical, LLC · 2012 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K870947 | Dynatron 500 | Dynatronics Corp. | 1987 | — |
| +1 | K952273 | Handmaster NMS1 | Neuromusclar Electrical Stimulation Systems, Ltd. | 1996 | — |
| +2 | K982482 | Handmaster NMS1 | N.E.S.S. Nuromuscular Electrical Stimulation Syst | 1998 | — |
| +2 | K031900 | Handmaster | Ness-Neuromuscular Electrical Stimulation Systems | 2003 | — |
| +3 | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| +4 | K110179 | Incontrol | Incontrol Medical, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 7 | 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 | 6 | 0 |
| 2026 | 5 | 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 19.7 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (67)
See all 672 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, K952273 (Neuromusclar Electrical Stimulation Systems, Ltd., 1996) has gone furthest, with 55 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/K870947 · printed Nov 4, 2026
Cite this page
510(k) Report. “K870947: Dynatron 500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K870947
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026