510(k) · Cleared
ClearedCompex Sport
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compex S.A. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Apr 17, 2002 as substantially equivalent to K940301 (Biodex Medical Systems, Inc., 1994) after a 306-day review. Its family tree reaches back 1 generation to 1994. 195 later devices descend from it.
- Decided
- Apr 17, 2002
- Review
- 306 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940301 (1994). 195 later devices descend from it, 12 citing it directly.
- Root · 1 generation backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- This deviceK011880 Compex SportCompex S.A. · 2002
- Descendant · cites it directly · 151 of its ownK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- Descendant · cites it directly · 78 of its ownK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- Descendant · 2 generations on · 58 of its ownK112392 Hivox Biotek Inc.Hivox Biotek, Inc. · 2012
- Descendant · 2 generations on · 55 of its ownK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- Descendant · 2 generations on · 50 of its ownK110068 Model PM3030Omron Healthcare, Inc. · 2011
Showing 5 of 195 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 195 · See all- K060846Therapeutic Massage CompanionEndurance Therapeutics · 2007 · cites it directly151descendants
- K102598HI-Dow-XPHi-Dow International, Inc. · 2011 · cites it directly78descendants
- K112392Hivox Biotek Inc.Hivox Biotek, Inc. · 2012 · 2 generations on58descendants
- K122744Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013 · 2 generations on55descendants
- K110068Model PM3030Omron Healthcare, Inc. · 2011 · 2 generations on50descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| 0 (this device) | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| +1 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| +1 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| +2 | K112392 | Hivox Biotek Inc. | Hivox Biotek, Inc. | 2012 | — |
| +2 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| +2 | K110068 | Model PM3030 | Omron Healthcare, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 10 | 0 |
| 2014 | 18 | 0 |
| 2015 | 13 | 0 |
| 2016 | 8 | 0 |
| 2017 | 16 | 0 |
| 2018 | 9 | 0 |
| 2019 | 18 | 0 |
| 2020 | 13 | 0 |
| 2021 | 16 | 0 |
| 2022 | 13 | 0 |
| 2023 | 12 | 0 |
| 2024 | 7 | 0 |
| 2025 | 14 | 0 |
| 2026 | 6 | 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? (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 |
|---|---|---|---|
| * | K940301 | Compex 2Summary page 2…eted Device "Compex® Sport" is a powered muscle stimulator substantially equivalent, in the perspective of technological characteristics, to "Compex® 2" (510(k) number: K940301). 1.2 Proposed Indications The proposed indications for "Compex® Sport" differ from those of the predicate device because it ha… | 1994 |
What descends from it? (195)
See all 19512 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060846 | Therapeutic Massage Companion | 2007 | 151 |
| K102598 | HI-Dow-XP | 2011 | 78 |
| K061632 | Globus Premium Muscle Stimulator | 2007 | 40 |
| K083140 | Compex Sport Plus | 2009 | 39 |
| K133225 | E-Fit EF-1280 Ems Machine | 2014 | 19 |
| K123158 | Ion Magnum Genius | 2013 | 7 |
| K031611 | P4-Fitness | 2004 | 5 |
| K111476 | Contour Technology Muscle Stimulator | 2012 | 4 |
| K071666 | Slendertone Enervive, Model 561 | 2008 | 4 |
| K081998 | H-Wave Sport | 2009 | 2 |
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?
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.
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?
"Compex® Sport" is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. "Compex® Sport" 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" training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The "Compex® Sport" electrical impulses allow triggering action…
Read the full statement (167 words)
"Compex® Sport" is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
"Compex® Sport" 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" training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
The "Compex® Sport" electrical impulses allow triggering 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 "Compex® Sport” can impose on the stimulated muscles are able to improve or facilitate muscle performance. "Compex® Sport" may therefore be considered a technique of muscle training.
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/K011880 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011880: Compex Sport.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011880
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026