510(k) · Cleared
ClearedTENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangxi Royall Smart Technology Co., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on May 22, 2023 as substantially equivalent to K163611 (Guangzhou Xinbo Electronic Co., Ltd., 2017) after a 90-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- May 22, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K940301 (1994). 28 ancestors in all, the oldest K872976 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 6 generations backK011880 Compex SportCompex S.A. · 2002
- 5 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 4 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- 3 generations backK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- 2 generations backK133929 Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited · 2014
- 1 generation backK163611 Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd. · 2017
- This deviceK230443 TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)Jiangxi Royall Smart Technology Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −6 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −5 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −4 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| −3 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| −2 | K133929 | Health Expert Elctronic Stimulator | Shenzhen Osto Technology Company Limited | 2014 | — |
| −1 | K163611 | Pain Therapy Device | Guangzhou Xinbo Electronic Co., Ltd. | 2017 | — |
| 0 (this device) | K230443 | TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) | Jiangxi Royall Smart Technology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 NUH? 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 NUH device
- #1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 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 |
|---|---|---|---|
| * | K163611 | Pain Therapy DeviceSummary page 5…II, P.T.S-IIA, P.T.S-IIB, CP-I Common Name: TENS, EMS, Stimulator for pain relief Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter 510(K) Number: K163611 Review Panel: Neurology Product Code: Primary product code: NUH Secondary product code: NGX, NYN Regulation Number: 21 CR… | 2017 |
| † | K150277 | Pain Therapy System, Model PTS-II | 2016 |
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 29 years and passes through 8 companies; a new generation was cleared every 3.4 years on median.
- None of the 28 ancestors has a recall.
- 1 other device also cites its predicate K163611.
How does its category compare?
All NUH devicesNUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · NUH
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUH
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUH
No recall names NUH since 2007.
Adverse event reports per year · NUH
7in 2025
MAUDE reports naming product code NUH, 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 | 4 | 161 | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 148 | 0 | 0 |
| 2011 | 6 | 231 | 0 | 0 |
| 2012 | 6 | 170 | 0 | 0 |
| 2013 | 10 | 189 | 0 | 1 |
| 2014 | 16 | 212 | 0 | 9 |
| 2015 | 14 | 198 | 0 | 11 |
| 2016 | 13 | 145 | 0 | 13 |
| 2017 | 17 | 155 | 0 | 21 |
| 2018 | 16 | 121 | 0 | 18 |
| 2019 | 19 | 213 | 0 | 5 |
| 2020 | 14 | 147 | 0 | 8 |
| 2021 | 14 | 198 | 0 | 7 |
| 2022 | 20 | 103 | 0 | 2 |
| 2023 | 15 | 127 | 0 | 4 |
| 2024 | 20 | 90 | 0 | 7 |
| 2025 | 15 | 119 | 0 | 7 |
| 2026 | 5 | 137 | 0 | — |
What is it indicated for?
TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04):
- To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
- To stimulate healthy muscles in order to improve and facilitate muscle performance .
- To temporarily increase local blood circulation in healthy muscles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230443: TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230443
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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