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 Jun 19, 2017 as substantially equivalent to K143551 (Djo, LLC, 2015) and 1 other predicate after an 83-day review. Its family tree reaches back 6 generations to 1988. 10 later devices descend from it.
- Decided
- Jun 19, 2017
- Review
- 83 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K881114 (1988). 31 ancestors in all, the oldest K872976 (1987). 10 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK881114 Empi Model 989, TensEmpi · 1988
- 5 generations backK970203 Epix VTEmpi · 1997
- 4 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 3 generations backK093324 Empi ContinuumEmpi · 2010
- 2 generations backK124016 Empi PhoenixDjo, LLC · 2013
- 1 generation backK153704 StriveDjo, LLC · 2016
- This deviceK170903 Compex Wireless USADjo, LLC · 2017
- Descendant · cites it directly · 3 of its ownK190966 Katalyst Training SystemKatalyst, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK181955 WiEMSproMedical Cables S.L. · 2019
- Descendant · 2 generations on · 1 of its ownK212413 I-MotionI-Motion Group Global Iberica S.L. · 2022
- Descendant · 2 generations on · 0 of its ownK233770 Pepper EMS Training SystemPepper Interactive, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK230261 Gnesis EMS PlusCreative Fitness Developments S.L. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K190966Katalyst Training SystemKatalyst, Inc. · 2020 · cites it directly3descendants
- K181955WiEMSproMedical Cables S.L. · 2019 · cites it directly3descendants
- K212413I-MotionI-Motion Group Global Iberica S.L. · 2022 · 2 generations on1descendant
- K233770Pepper EMS Training SystemPepper Interactive, Inc. · 2025 · 2 generations on0descendants
- K230261Gnesis EMS PlusCreative Fitness Developments S.L. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −5 | K970203 | Epix VT | Empi | 1997 | — |
| −4 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −3 | K093324 | Empi Continuum | Empi | 2010 | — |
| −2 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
| −1 | K153704 | Strive | Djo, LLC | 2016 | — |
| 0 (this device) | K170903 | Compex Wireless USA | Djo, LLC | 2017 | — |
| +1 | K190966 | Katalyst Training System | Katalyst, Inc. | 2020 | — |
| +1 | K181955 | WiEMSpro | Medical Cables S.L. | 2019 | — |
| +2 | K212413 | I-Motion | I-Motion Group Global Iberica S.L. | 2022 | — |
| +2 | K233770 | Pepper EMS Training System | Pepper Interactive, Inc. | 2025 | — |
| +2 | K230261 | Gnesis EMS Plus | Creative Fitness Developments S.L. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K143551 | Compex Wireless USASummary page 4…Product Code NYN (subsequent code); Review Panel: Neurology Regulatory Class: Class II Predicate Device: Compex Wireless USA (K143551) Strive (K153704) Device Description: The Compex Wireless USA employs programs for neuromuscu… | 2015 |
| * | K153704 | StriveSummary page 4…eview Panel: Neurology Regulatory Class: Class II Predicate Device: Compex Wireless USA (K143551) Strive (K153704) Device Description: The Compex Wireless USA employs programs for neuromuscular electrical stimulation (NMES) and transcutaneo… | 2016 |
What descends from it? (10)
4 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 29 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 31 ancestors has a recall of any class.
- Of its descendants, K190966 (Katalyst, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K143551.
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. 2017, 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 (228 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.
The Compex Wireless USA TENS is used for:
• temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
• the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170903 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170903: Compex Wireless USA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170903
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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