510(k) · Cleared
ClearedCompex Wireless USA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Djo, LLC · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Apr 28, 2015 as substantially equivalent to K083140 (Chattanooga Group, 2009) after a 134-day review. Its family tree reaches back 4 generations to 1994. 20 later devices descend from it.
- Decided
- Apr 28, 2015
- Review
- 134 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940301 (1994). 20 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 3 generations backK011880 Compex SportCompex S.A. · 2002
- 2 generations backK061632 Globus Premium Muscle StimulatorDomino S.R.L. · 2007
- 1 generation backK083140 Compex Sport PlusChattanooga Group · 2009
- This deviceK143551 Compex Wireless USADjo, LLC · 2015
- Descendant · cites it directly · 10 of its ownK170903 Compex Wireless USADjo, LLC · 2017
- Descendant · cites it directly · 5 of its ownK182440 Body SystemA-1 Engineering · 2019
- Descendant · 2 generations on · 3 of its ownK190966 Katalyst Training SystemKatalyst, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK181955 WiEMSproMedical Cables S.L. · 2019
- Descendant · 2 generations on · 2 of its ownK213308 Venus BlissMAXVenus Concept USA, Inc. · 2022
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K170903Compex Wireless USADjo, LLC · 2017 · cites it directly10descendants
- K182440Body SystemA-1 Engineering · 2019 · cites it directly5descendants
- K190966Katalyst Training SystemKatalyst, Inc. · 2020 · 2 generations on3descendants
- K181955WiEMSproMedical Cables S.L. · 2019 · 2 generations on3descendants
- K213308Venus BlissMAXVenus Concept USA, Inc. · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −3 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −2 | K061632 | Globus Premium Muscle Stimulator | Domino S.R.L. | 2007 | — |
| −1 | K083140 | Compex Sport Plus | Chattanooga Group | 2009 | — |
| 0 (this device) | K143551 | Compex Wireless USA | Djo, LLC | 2015 | — |
| +1 | K170903 | Compex Wireless USA | Djo, LLC | 2017 | — |
| +1 | K182440 | Body System | A-1 Engineering | 2019 | — |
| +2 | K190966 | Katalyst Training System | Katalyst, Inc. | 2020 | — |
| +2 | K181955 | WiEMSpro | Medical Cables S.L. | 2019 | — |
| +2 | K213308 | Venus BlissMAX | Venus Concept USA, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K083140 | Compex Sport PlusSummary page 4…ered muscle stimulator, for muscle conditioning. Regulatory Class: Class II Predicate Device: Compex Sport Elite (k083140) Device Description: The Compex Wireless USA is a neuromuscular electrical stimulation (NMES) device, which stimulates nerve fi… | 2009 |
| † | K112050 | Soundstar Eco Diagnostic Ultrasound Catheter | 2011 |
What descends from it? (20)
See all 204 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 21 years and passes through 5 companies; a new generation was cleared every 6.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K170903 (Djo, LLC, 2017) has gone furthest, with 10 descendants of its own.
- 8 other devices also cite its predicate K083140.
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. 2015, 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 Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated.…
Read the full statement (181 words)
The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy
muscles in order to improve or facilitate muscle performance. It is to be used by adults
only.
The Compex Wireless USA is not intended for adjunctive therapy in the treatment of
medical diseases and conditions of any kind. None of the Compex Wireless USA
stimulation programs are designed for injured or disease afflicted muscles. Its use on
such muscles is contraindicated. The work imposed on the muscles by the Compex
Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy.
The Compex Wireless USA 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 Compex Wireless USA may therefore be considered a technique of muscle
training.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143551: Compex Wireless USA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143551
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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