510(k) · Cleared
ClearedOrtho DX Neuromuscular Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rehabilicare, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Aug 14, 1997 as substantially equivalent to K881082 (Medical Devices, Inc., 1988) and 1 other predicate after a 108-day review. Its family tree reaches back 1 generation to 1984. 4 later devices descend from it.
- Decided
- Aug 14, 1997
- Review
- 108 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K840346 (1984). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK840346 Neuromusclar IIMentor Corp. · 1984
- This deviceK971542 Ortho DX Neuromuscular StimulatorRehabilicare, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK021905 Classic NMSCare Rehab, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK091236 Mantra Combo, Model Mecs 320Mantra Intl. (Hk), Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK030403 Cefar Rehab 2 and Rehab 2 ProCefar Medical AB · 2003
- Descendant · cites it directly · 0 of its ownK020637 Select StimCare Rehab and Orthopaedic · 2002
Most influential descendants
Showing 4 of 4 · See all- K021905Classic NMSCare Rehab, Inc. · 2002 · cites it directly1descendant
- K091236Mantra Combo, Model Mecs 320Mantra Intl. (Hk), Ltd. · 2009 · 2 generations on0descendants
- K030403Cefar Rehab 2 and Rehab 2 ProCefar Medical AB · 2003 · cites it directly0descendants
- K020637Select StimCare Rehab and Orthopaedic · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K840346 | Neuromusclar II | Mentor Corp. | 1984 | — |
| 0 (this device) | K971542 | Ortho DX Neuromuscular Stimulator | Rehabilicare, Inc. | 1997 | — |
| +1 | K021905 | Classic NMS | Care Rehab, Inc. | 2002 | — |
| +2 | K091236 | Mantra Combo, Model Mecs 320 | Mantra Intl. (Hk), Ltd. | 2009 | — |
| +1 | K030403 | Cefar Rehab 2 and Rehab 2 Pro | Cefar Medical AB | 2003 | — |
| +1 | K020637 | Select Stim | Care Rehab and Orthopaedic | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 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 19.6 · 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? (3)
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 |
|---|---|---|---|
| * | K881082 | GV 11 (TM), Model 9700Summary page 1…Brighton, MN 55112 Phone No. (612) 631-0590 Contact: Gary L. Moore Phone No. (612) 638-0437 Predicate Products: - GV II ™ Neuromuscular Stimulator, Model 9700/7000S, K881082 - Neuromuscular [T (NMIII ™) Model 6800S, K840346 - TRI-STIM Stimulator, Muscle, Electrical Powered, Registration No. not known… | 1988 |
| * | K840346 | Neuromusclar IISummary page 1…ct: Gary L. Moore Phone No. (612) 638-0437 Predicate Products: - GV II ™ Neuromuscular Stimulator, Model 9700/7000S, K881082 - Neuromuscular [T (NMIII ™) Model 6800S, K840346 - TRI-STIM Stimulator, Muscle, Electrical Powered, Registration No. not known Indications For Use: The Ortho Dy, a non-invasive… | 1984 |
| * | — | TRI-STIM Stimulator, Muscle, Electrical Powered Named without a submission number |
What descends from it? (4)
3 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K021905 (Care Rehab, Inc., 2002) has gone furthest, with 1 descendant 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?
The Ortho Dy, a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation to be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. It is used to, relax muscle spasm, prevent or retard disuse atrophy, increase local blood circulation, reeducate muscles, prevent venous thrombosis with immediate post surgical stimulation in calf muscles, and increase range of motion.
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/K971542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971542: Ortho DX Neuromuscular Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971542
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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