510(k) · Cleared
ClearedPortable Electro-Stimulation Therapy Device, Model: LGT-232(US)
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 Oct 8, 2020 as substantially equivalent to K170903 (Djo, LLC, 2017) and 1 other predicate after a 94-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- Oct 8, 2020
- Review
- 94 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K881114 (1988). 35 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 backK170903 Compex Wireless USADjo, LLC · 2017
- This deviceK201845 Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)Guangzhou 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 | K170903 | Compex Wireless USA | Djo, LLC | 2017 | — |
| 0 (this device) | K201845 | Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) | 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 |
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K170903 | Compex Wireless USASummary page 5…TENS and Muscle Stimulator Compex Wireless USA (Model AS8012) 510(k) Number K170903 K200727 Product Code NGX, NUH, NYN NUH, NGX Regulation… | 2017 |
| * | K200727 | TENS and Muscle StimulatorSummary page 5…TENS and Muscle Stimulator Compex Wireless USA (Model AS8012) 510(k) Number K170903 K200727 Product Code NGX, NUH, NYN NUH, NGX Regulation 21 CFR… | 2020 |
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 35 ancestors has a recall of any class.
- 3 other devices also cite its predicate K170903.
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?
The Portable Electro-Stimulation Therapy Device, model LGT-232(US) is used to: Stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
Portable Electro-Stimulation Therapy Device, model LGT-232(US) in TENS mode is used for:
1. Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities;
2. 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/K201845 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201845: Portable Electro-Stimulation Therapy Device, Model: LGT-232(US).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201845
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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