510(k) · Cleared
ClearedCompex Sport Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chattanooga Group · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Feb 9, 2009 as substantially equivalent to K011880 (Compex S.A., 2002) and 1 other predicate after a 109-day review. Its family tree reaches back 3 generations to 1994. 39 later devices descend from it.
- Decided
- Feb 9, 2009
- Review
- 109 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940301 (1994). 39 later devices descend from it, 9 citing it directly.
- Root · 3 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 2 generations backK011880 Compex SportCompex S.A. · 2002
- 1 generation backK061632 Globus Premium Muscle StimulatorDomino S.R.L. · 2007
- This deviceK083140 Compex Sport PlusChattanooga Group · 2009
- Descendant · cites it directly · 20 of its ownK143551 Compex Wireless USADjo, LLC · 2015
- Descendant · 2 generations on · 10 of its ownK170903 Compex Wireless USADjo, LLC · 2017
- Descendant · 2 generations on · 5 of its ownK182440 Body SystemA-1 Engineering · 2019
- Descendant · cites it directly · 4 of its ownK170918 Compex Sport EliteDjo, LLC · 2017
- Descendant · 3 generations on · 3 of its ownK190966 Katalyst Training SystemKatalyst, Inc. · 2020
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K143551Compex Wireless USADjo, LLC · 2015 · cites it directly20descendants
- K170903Compex Wireless USADjo, LLC · 2017 · 2 generations on10descendants
- K182440Body SystemA-1 Engineering · 2019 · 2 generations on5descendants
- K170918Compex Sport EliteDjo, LLC · 2017 · cites it directly4descendants
- K190966Katalyst Training SystemKatalyst, Inc. · 2020 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −2 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −1 | K061632 | Globus Premium Muscle Stimulator | Domino S.R.L. | 2007 | — |
| 0 (this device) | K083140 | Compex Sport Plus | Chattanooga Group | 2009 | — |
| +1 | K143551 | Compex Wireless USA | Djo, LLC | 2015 | — |
| +2 | K170903 | Compex Wireless USA | Djo, LLC | 2017 | — |
| +2 | K182440 | Body System | A-1 Engineering | 2019 | — |
| +1 | K170918 | Compex Sport Elite | Djo, LLC | 2017 | — |
| +3 | K190966 | Katalyst Training System | Katalyst, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 NGX? 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 NGX device
- #1 K250146 SofWave Systemscore 15.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K011880 | Compex SportSummary page 4…e fatigue and to help recover muscle strength after training sessions and competitions. Substantial Equivalence: When compared to the predicated device, Compex® Sport (011880) and Globus Premium Sport and fitness Muscle Stimulators (K061632), the Compex® Sport Plus has the same intended use. Therefore,… | 2002 |
| * | K061632 | Globus Premium Muscle StimulatorSummary page 1…890.5850) Predicate Device: Compex® Sport (KO I1880) Globus Premium Sport and fitness Muscle Stimulators (K061632) Indications for Use: The Compex® Sport Plus is intended to stimulate healthy muscles in order to improve or facilitate… | 2007 |
What descends from it? (39)
See all 399 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143551 | Compex Wireless USA | 2015 | 20 |
| K170918 | Compex Sport Elite | 2017 | 4 |
| K162479 | Smart Pain Reliever, Model LT5019 | 2017 | 3 |
| K150078 | PowerDot (R) PD-01 Muscle Stimulator (with PowerDot (R) Mobile Application) | 2015 | 2 |
| K181199 | Katalyst Mark 1 Muscle Stimulation System Model 2 | 2018 | 1 |
| K134001 | Firefly | 2014 | 1 |
| K171035 | Katalyst Mark 1 Muscle Stimulation System | 2017 | 0 |
| K152420 | AK Body Toning Device | 2016 | 0 |
| K141919 | Veinoplus Sport Neuromuscular Stimulator | 2015 | 0 |
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 15 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K143551 (Djo, LLC, 2015) has gone furthest, with 20 descendants of its own.
- 11 other devices also cite its predicate K011880.
How does its category compare?
All NGX devicesNGX Stimulator, Muscle, Powered, For Muscle Conditioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NGX
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGX
93in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGX
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NGX
15in 2025
MAUDE reports naming product code NGX, 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 | 7 | 135 | 0 | 0 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 4 | 132 | 0 | 0 |
| 2010 | 6 | 180 | 0 | 0 |
| 2011 | 5 | 291 | 0 | 1 |
| 2012 | 3 | 362 | 0 | 0 |
| 2013 | 6 | 269 | 2 | 1 |
| 2014 | 6 | 298 | 0 | 0 |
| 2015 | 9 | 184 | 0 | 7 |
| 2016 | 4 | 240 | 0 | 21 |
| 2017 | 10 | 108 | 0 | 2 |
| 2018 | 6 | 104 | 0 | 6 |
| 2019 | 14 | 167 | 0 | 4 |
| 2020 | 11 | 207 | 0 | 7 |
| 2021 | 12 | 256 | 0 | 5 |
| 2022 | 6 | 307 | 0 | 7 |
| 2023 | 12 | 96 | 0 | 8 |
| 2024 | 12 | 207 | 0 | 11 |
| 2025 | 15 | 93 | 0 | 15 |
| 2026 | 4 | 118 | 0 | — |
What is it indicated for?
The Compex® Sport Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Compex® Sport Plus is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Compex® Sport Plus training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Compex® Sport Plus electrical impulses allow the…
Read the full statement (179 words)
The Compex® Sport Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The Compex® Sport Plus is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Compex® Sport Plus training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
The Compex® Sport Plus electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
The various types of muscle work that the Compex® Sport Plus can impose on the stimulated muscles are able to improve or facilitate muscle performance.
The Compex® Sport Plus may therefore be considered a technique of muscle training.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083140: Compex Sport Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083140
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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