510(k) · Cleared
ClearedNXPRO Neuromuscular Electrical Stimulation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neux Technologies, Inc. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Oct 11, 2019 as substantially equivalent to K093999 (Arp Manufacturing, Inc., 2010) after a 162-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Oct 11, 2019
- Review
- 162 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940301 (1994). 7 ancestors in all, the oldest K893851 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 3 generations backK011880 Compex SportCompex S.A. · 2002
- 2 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 1 generation backK093999 Arp Pov SportArp Manufacturing, Inc. · 2010
- This deviceK191181 NXPRO Neuromuscular Electrical Stimulation DeviceNeux Technologies, Inc. · 2019
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 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −1 | K093999 | Arp Pov Sport | Arp Manufacturing, Inc. | 2010 | — |
| 0 (this device) | K191181 | NXPRO Neuromuscular Electrical Stimulation Device | Neux Technologies, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K093999 | Arp Pov SportSummary page 4…(890.5850), Product Code NGX Predicate Device – ARP Manufacturing – ARP Sport Device (K093999) Reference Device – N/A 510(k) Summary (NeuX – NXPRO Device)… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 5 companies; a new generation was cleared every 7.3 years on median.
- None of the 7 ancestors has a recall.
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. 2019, 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 NeuX NXPRO Neuromuscular Electrical Stimulation Device is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The NeuX NXPRO is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The NeuX NXPRO is not designed for use on injured or ailing muscles and its use on such muscles is contraindicated. The NeuX NXPRO’s electrical impulses…
Read the full statement (177 words)
The NeuX NXPRO Neuromuscular Electrical Stimulation Device is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
The NeuX NXPRO is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The NeuX NXPRO is not designed for use on injured or ailing muscles and its use on such muscles is contraindicated.
The NeuX NXPRO’s electrical impulses allow triggering action potential on motor neurons of motor nerves (excitations). These excitations of motor neurons 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 NeuX NXPRPO can impose on the stimulated muscles are able to improve or facilitate muscle performance. The NeuX NXPRO is considered a technique of muscle training.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191181: NXPRO Neuromuscular Electrical Stimulation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191181
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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