510(k) · Cleared
ClearedPortable Electro-Stimulation Therapy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Longest Science & Technology Co., Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Sep 17, 2020 as substantially equivalent to K170918 (Djo, LLC, 2017) after a 783-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- Sep 17, 2020
- Review
- 783 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K881114 (1988). 31 ancestors in all, the oldest K872976 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK881114 Empi Model 989, TensEmpi · 1988
- 6 generations backK970203 Epix VTEmpi · 1997
- 5 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 4 generations backK093324 Empi ContinuumEmpi · 2010
- 3 generations backK124016 Empi PhoenixDjo, LLC · 2013
- 2 generations backK153704 StriveDjo, LLC · 2016
- 1 generation backK170918 Compex Sport EliteDjo, LLC · 2017
- This deviceK182020 Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −6 | K970203 | Epix VT | Empi | 1997 | — |
| −5 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −4 | K093324 | Empi Continuum | Empi | 2010 | — |
| −3 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
| −2 | K153704 | Strive | Djo, LLC | 2016 | — |
| −1 | K170918 | Compex Sport Elite | Djo, LLC | 2017 | — |
| 0 (this device) | K182020 | Portable Electro-Stimulation Therapy Device | Guangzhou Longest Science & Technology Co., Ltd. | 2020 | — |
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 |
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 |
|---|---|---|---|
| * | K170918 | Compex Sport EliteSummary page 5…5850, 21 CFR 882.5890 3. Predicate Device Information 1 510(k) submitter/holder: DJO, LLC 510(K) Number: K170918 Device: Compex Sport Elite Trade name: Compex Sport Elite Regulation name: Powered muscle stimulator.… | 2017 |
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 32 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 31 ancestors has a recall of any class.
- 1 other device also cites its predicate K170918.
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. 2020, 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?
Portable Electro-Stimulation Therapy Device, model LGT-231 is to be used by adults only and has two modes NMES, TENS.
NMES is used to: stimulate healthy muscles in order to improve or facilitate muscle performance.
TENS is used to:
1. Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
2. 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/K182020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182020: Portable Electro-Stimulation Therapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182020
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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