510(k) · Cleared
ClearedWireless Pain Relieve Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Dongdixin Technology Co., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Jun 22, 2018 as substantially equivalent to K173462 (Shenzhen Dongdixin Technology Co., Ltd., 2017) after a 136-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- Jun 22, 2018
- Review
- 136 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K881114 (1988). 18 ancestors in all. 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 backK113037 Pain-AidPdi Works, LLC · 2012
- 3 generations backK131159 SmartreliefChattem, Inc. · 2013
- 2 generations backK162479 Smart Pain Reliever, Model LT5019Shenzhen Dongdixin Technology Co., Ltd. · 2017
- 1 generation backK173462 Wireless Pain Relieve Device Model: LT5018CShenzhen Dongdixin Technology Co., Ltd. · 2017
- This deviceK180331 Wireless Pain Relieve DeviceShenzhen Dongdixin Technology Co., Ltd. · 2018
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 | K113037 | Pain-Aid | Pdi Works, LLC | 2012 | — |
| −3 | K131159 | Smartrelief | Chattem, Inc. | 2013 | — |
| −2 | K162479 | Smart Pain Reliever, Model LT5019 | Shenzhen Dongdixin Technology Co., Ltd. | 2017 | — |
| −1 | K173462 | Wireless Pain Relieve Device Model: LT5018C | Shenzhen Dongdixin Technology Co., Ltd. | 2017 | — |
| 0 (this device) | K180331 | Wireless Pain Relieve Device | Shenzhen Dongdixin Technology Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K173462 | Wireless Pain Relieve Device Model: LT5018CSummary page 5…Device Class: II 2. Predicate Device: Legally Marketed Device: Wireless Pain Relieve Device LT5018C 510(k) Number: K173462 Manufacturer: Shenzhen Dondixin Technology Co., Ltd. 3. Description of Proposed Device: LT5011C is… | 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 30 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 18 ancestors has a recall.
- 1 other device also cites its predicate K173462.
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. 2018, 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?
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder,
waist, back, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work
activities. And to be used for 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/K180331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180331: Wireless Pain Relieve Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180331
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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