510(k) · Cleared
ClearedGV 11 (TM), Model 9700
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Devices, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Mar 28, 1988 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Mar 28, 1988
- Review
- 14 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK881082 GV 11 (TM), Model 9700Medical Devices, Inc. · 1988
- Descendant · cites it directly · 4 of its ownK971542 Ortho DX Neuromuscular StimulatorRehabilicare, Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK021905 Classic NMSCare Rehab, Inc. · 2002
- Descendant · 3 generations on · 0 of its ownK091236 Mantra Combo, Model Mecs 320Mantra Intl. (Hk), Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK030403 Cefar Rehab 2 and Rehab 2 ProCefar Medical AB · 2003
- Descendant · 2 generations on · 0 of its ownK020637 Select StimCare Rehab and Orthopaedic · 2002
Most influential descendants
Showing 5 of 5 · See all- K971542Ortho DX Neuromuscular StimulatorRehabilicare, Inc. · 1997 · cites it directly4descendants
- K021905Classic NMSCare Rehab, Inc. · 2002 · 2 generations on1descendant
- K091236Mantra Combo, Model Mecs 320Mantra Intl. (Hk), Ltd. · 2009 · 3 generations on0descendants
- K030403Cefar Rehab 2 and Rehab 2 ProCefar Medical AB · 2003 · 2 generations on0descendants
- K020637Select StimCare Rehab and Orthopaedic · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K881082 | GV 11 (TM), Model 9700 | Medical Devices, Inc. | 1988 | — |
| +1 | K971542 | Ortho DX Neuromuscular Stimulator | Rehabilicare, Inc. | 1997 | — |
| +2 | K021905 | Classic NMS | Care Rehab, Inc. | 2002 | — |
| +3 | K091236 | Mantra Combo, Model Mecs 320 | Mantra Intl. (Hk), Ltd. | 2009 | — |
| +2 | K030403 | Cefar Rehab 2 and Rehab 2 Pro | Cefar Medical AB | 2003 | — |
| +2 | K020637 | Select Stim | Care Rehab and Orthopaedic | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2009 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971542 | Ortho DX Neuromuscular Stimulator | 1997 | 4 |
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, K971542 (Rehabilicare, Inc., 1997) has gone furthest, with 4 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/K881082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K881082: GV 11 (TM), Model 9700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881082
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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