510(k) · Cleared
ClearedSM Tens & PMS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hong Qiangxing (Shenzhen) Electronics Limited · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on May 10, 2013 as substantially equivalent to K102598 (Hi-Dow International, Inc., 2011) after a 333-day review. Its family tree reaches back 4 generations to 1994. 30 later devices descend from it.
- Decided
- May 10, 2013
- Review
- 333 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940301 (1994). 6 ancestors in all. 30 later devices descend from it, 3 citing it directly.
- 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 backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- This deviceK121719 SM Tens & PMSHong Qiangxing (Shenzhen) Electronics Limited · 2013
- Descendant · cites it directly · 26 of its ownK133929 Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited · 2014
- Descendant · 2 generations on · 6 of its ownK190783 Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited · 2020
- Descendant · 2 generations on · 3 of its ownK172897 Neck Care Therapy, Model: SYK 509BShenzhen Osto Technology Co., Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK191982 Low-Frequency Multi-function Physiotherapy Instrument (Model…Shenzhen Kentro Medical Electronics Co., Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK163611 Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd. · 2017
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K133929Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited · 2014 · cites it directly26descendants
- K190783Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited · 2020 · 2 generations on6descendants
- K172897Neck Care Therapy, Model: SYK 509BShenzhen Osto Technology Co., Ltd. · 2018 · 2 generations on3descendants
- K191982Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220…Shenzhen Kentro Medical Electronics Co., Ltd. · 2020 · 2 generations on2descendants
- K163611Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd. · 2017 · 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 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −1 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| 0 (this device) | K121719 | SM Tens & PMS | Hong Qiangxing (Shenzhen) Electronics Limited | 2013 | — |
| +1 | K133929 | Health Expert Elctronic Stimulator | Shenzhen Osto Technology Company Limited | 2014 | — |
| +2 | K190783 | Health Expert Electronic Stimulator (model: AST-300L) | Shenzhen Osto Technology Company Limited | 2020 | — |
| +2 | K172897 | Neck Care Therapy, Model: SYK 509B | Shenzhen Osto Technology Co., Ltd. | 2018 | — |
| +2 | K191982 | Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230… | Shenzhen Kentro Medical Electronics Co., Ltd. | 2020 | — |
| +2 | K163611 | Pain Therapy Device | Guangzhou Xinbo Electronic Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 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 |
|---|---|---|---|
| * | K102598 | HI-Dow-XPSummary page 2…f this 510(k) * Iuis intended to be used to stimulate healthy muscles in order to improve submission, Parameters New Device Predicate Device 1. | 510(k) Number K121719 K102598 2 Marketing clcarance date: - May 13, 2011 kX Device Name SM TENS & PMS Powered Muscle Stimulator, JQ-5C 4 Monufacturer Hong Qian… | 2011 |
| † | K092546 | Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM, CWN1007.Dia. 7CM… | 2009 |
What descends from it? (30)
See all 303 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 19 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K133929 (Shenzhen Osto Technology Company Limited, 2014) has gone furthest, with 26 descendants of its own.
- 8 other devices also cite its predicate K102598.
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. 2013, 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?
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121719: SM Tens & PMS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121719
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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