510(k) · Cleared
ClearedCompex Rehab
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chattanooga Group · IPF Stimulator, Muscle, Powered
Cleared on Jun 1, 2009 as substantially equivalent to K071431 (Domino S.R.L., 2007) after an 84-day review. Its family tree reaches back 2 generations to 2003. 28 later devices descend from it.
- Decided
- Jun 1, 2009
- Review
- 84 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K031077 (2003). 28 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK031077 Vectra Epr System and Intelect Epr SystemChattanooga Group · 2003 · Recalled
- 1 generation backK071431 Globus Genesy 1100 StimulatorDomino S.R.L. · 2007
- This deviceK090632 Compex RehabChattanooga Group · 2009
- Descendant · cites it directly · 25 of its ownK124016 Empi PhoenixDjo, LLC · 2013
- Descendant · 2 generations on · 24 of its ownK153704 StriveDjo, LLC · 2016
- Descendant · 3 generations on · 10 of its ownK170903 Compex Wireless USADjo, LLC · 2017
- Descendant · 3 generations on · 7 of its ownK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 4 generations on · 4 of its ownK191151 JKH Stimulator PlusJkh USA, LLC · 2019
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K124016Empi PhoenixDjo, LLC · 2013 · cites it directly25descendants
- K153704StriveDjo, LLC · 2016 · 2 generations on24descendants
- K170903Compex Wireless USADjo, LLC · 2017 · 3 generations on10descendants
- K182203JKH Stimulator PlusJkh USA, LLC · 2019 · 3 generations on7descendants
- K191151JKH Stimulator PlusJkh USA, LLC · 2019 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031077 | Vectra Epr System and Intelect Epr System | Chattanooga Group | 2003 | 17 |
| −1 | K071431 | Globus Genesy 1100 Stimulator | Domino S.R.L. | 2007 | — |
| 0 (this device) | K090632 | Compex Rehab | Chattanooga Group | 2009 | — |
| +1 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
| +2 | K153704 | Strive | Djo, LLC | 2016 | — |
| +3 | K170903 | Compex Wireless USA | Djo, LLC | 2017 | — |
| +3 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +4 | K191151 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K071431 | Globus Genesy 1100 StimulatorSummary page 1…me Compex® Rehab IPF stimulator, muscle, powered (21 CFR 890.5850) Predicate Device: Globus Genesy 1100 Electro-Stimulator (K07143 1) with the following intended use: The Globus Genesy 1100 Electro-stimu… | 2007 |
What descends from it? (28)
See all 283 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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K124016 (Djo, LLC, 2013) has gone furthest, with 25 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. 2009, this device’s year, is highlighted.
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 Compex® Rehab is an adjunctive multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (NMES).
The Compex® Rehab is indicated for the following conditions:
* Re-educating muscles
* Relaxation of muscle spasm
* Increasing local blood circulation
* Retarding or preventing disuse atrophy
* Maintaining or increasing range of motion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090632 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090632: Compex Rehab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090632
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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