510(k) · Cleared
ClearedSmart Pain Reliever, Model LT5019
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 Feb 8, 2017 as substantially equivalent to K151035 (Philips Consumer Lifestyle, 2015) and 2 other predicates after a 155-day review. Its family tree reaches back 5 generations to 1988. 3 later devices descend from it.
- Decided
- Feb 8, 2017
- Review
- 155 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K881114 (1988). 16 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK881114 Empi Model 989, TensEmpi · 1988
- 4 generations backK970203 Epix VTEmpi · 1997
- 3 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 2 generations backK113037 Pain-AidPdi Works, LLC · 2012
- 1 generation backK131159 SmartreliefChattem, Inc. · 2013
- This deviceK162479 Smart Pain Reliever, Model LT5019Shenzhen Dongdixin Technology Co., Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK173462 Wireless Pain Relieve Device Model: LT5018CShenzhen Dongdixin Technology Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK181102 ThermaCare Quick Therapy TENSPfizer, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK180331 Wireless Pain Relieve DeviceShenzhen Dongdixin Technology Co., Ltd. · 2018
Most influential descendants
Showing 3 of 3 · See all- K173462Wireless Pain Relieve Device Model: LT5018CShenzhen Dongdixin Technology Co., Ltd. · 2017 · cites it directly2descendants
- K181102ThermaCare Quick Therapy TENSPfizer, Inc. · 2018 · 2 generations on0descendants
- K180331Wireless Pain Relieve DeviceShenzhen Dongdixin Technology Co., Ltd. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −4 | K970203 | Epix VT | Empi | 1997 | — |
| −3 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −2 | K113037 | Pain-Aid | Pdi Works, LLC | 2012 | — |
| −1 | K131159 | Smartrelief | Chattem, Inc. | 2013 | — |
| 0 (this device) | 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 | — |
| +2 | K181102 | ThermaCare Quick Therapy TENS | Pfizer, Inc. | 2018 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K151035 | PulseReliefSummary page 5…Device Class: II 2. Predicate Device: No. Legally Marketed Device: 510(k) Number: Manufacturer: 1 PulseRelief K151035 Philips Consumer Lifestyle 2 SmartRelief K131159 Chattem, Inc. 3 C… | 2015 |
| * | K131159 | SmartreliefSummary page 5…510(k) Number: Manufacturer: 1 PulseRelief K151035 Philips Consumer Lifestyle 2 SmartRelief K131159 Chattem, Inc. 3 Compex® Sport Plus K083140 Compex S.A. “MASSAGE” pro… | 2013 |
| * | K083140 | Compex Sport PlusSummary page 5…K151035 Philips Consumer Lifestyle 2 SmartRelief K131159 Chattem, Inc. 3 Compex® Sport Plus K083140 Compex S.A. “MASSAGE” program 3. Description of Proposed Device: LT5019 is designed to be used at ho… | 2009 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173462 | Wireless Pain Relieve Device Model: LT5018C | 2017 | 2 |
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 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K173462 (Shenzhen Dongdixin Technology Co., Ltd., 2017) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K151035.
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. 2017, 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: The device is designed 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. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS: The device is designed to be used for 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/K162479 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162479: Smart Pain Reliever, Model LT5019.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162479
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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