510(k) · Cleared
ClearedSmartrelief
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chattem, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Jul 25, 2013 as substantially equivalent to K113037 (Pdi Works, LLC, 2012) after a 92-day review. Its family tree reaches back 4 generations to 1988. 32 later devices descend from it.
- Decided
- Jul 25, 2013
- Review
- 92 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K881114 (1988). 11 ancestors in all. 32 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK881114 Empi Model 989, TensEmpi · 1988
- 3 generations backK970203 Epix VTEmpi · 1997
- 2 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 1 generation backK113037 Pain-AidPdi Works, LLC · 2012
- This deviceK131159 SmartreliefChattem, Inc. · 2013
- Descendant · cites it directly · 24 of its ownK153704 StriveDjo, LLC · 2016
- Descendant · 2 generations on · 10 of its ownK170903 Compex Wireless USADjo, LLC · 2017
- Descendant · 2 generations on · 7 of its ownK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 3 generations on · 4 of its ownK191151 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 2 generations on · 4 of its ownK170918 Compex Sport EliteDjo, LLC · 2017
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K153704StriveDjo, LLC · 2016 · cites it directly24descendants
- K170903Compex Wireless USADjo, LLC · 2017 · 2 generations on10descendants
- K182203JKH Stimulator PlusJkh USA, LLC · 2019 · 2 generations on7descendants
- K191151JKH Stimulator PlusJkh USA, LLC · 2019 · 3 generations on4descendants
- K170918Compex Sport EliteDjo, LLC · 2017 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −3 | K970203 | Epix VT | Empi | 1997 | — |
| −2 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −1 | K113037 | Pain-Aid | Pdi Works, LLC | 2012 | — |
| 0 (this device) | K131159 | Smartrelief | Chattem, Inc. | 2013 | — |
| +1 | K153704 | Strive | Djo, LLC | 2016 | — |
| +2 | K170903 | Compex Wireless USA | Djo, LLC | 2017 | — |
| +2 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +3 | K191151 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +2 | K170918 | Compex Sport Elite | Djo, LLC | 2017 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K113037 | Pain-AidSummary page 1…dicate Devices: The Chattern SmartRelief is of comparable type and Substantially equivalent to the following predicate device: PDI Works Pain-Aid. K 113037 4. Device Description: The SmiartRelief is a transcutaneouIs electrical nerve stimnulator for relief Of muscular pain a… | 2012 |
What descends from it? (32)
See all 324 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 25 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K153704 (Djo, LLC, 2016) has gone furthest, with 24 descendants of its own.
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. 2013, 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?
To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
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/K131159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131159: Smartrelief.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131159
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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