510(k) · Cleared
ClearedTens Back Pain Relief System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Savia Limited · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Sep 4, 2012 as substantially equivalent to K063660 (Well-Life Healthcare Limited, 2007) after a 299-day review. Its family tree reaches back 3 generations to 2004. 2 later devices descend from it.
- Decided
- Sep 4, 2012
- Review
- 299 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K040512 (2004). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK040512 Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A…Well-Life Healthcare, Inc. · 2004
- 2 generations backK052785 Otc Tens for Low Back Pain Relief, Model WL-2405 and WL-2406Well-Life Healthcare Limited · 2006
- 1 generation backK063660 Otc Tens for Low Back Pain Relief, Model WL-2407Well-Life Healthcare Limited · 2007
- This deviceK113321 Tens Back Pain Relief SystemSavia Limited · 2012
- Descendant · cites it directly · 1 of its ownK151693 Dr-Ho's Foot Pad ElectrodeDrtv Asia, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK172887 XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II…Guangzhou Xinbo Electronic Co., Ltd. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040512 | Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and… | Well-Life Healthcare, Inc. | 2004 | — |
| −2 | K052785 | Otc Tens for Low Back Pain Relief, Model WL-2405 and WL-2406 | Well-Life Healthcare Limited | 2006 | — |
| −1 | K063660 | Otc Tens for Low Back Pain Relief, Model WL-2407 | Well-Life Healthcare Limited | 2007 | — |
| 0 (this device) | K113321 | Tens Back Pain Relief System | Savia Limited | 2012 | — |
| +1 | K151693 | Dr-Ho's Foot Pad Electrode | Drtv Asia, Ltd. | 2015 | — |
| +2 | K172887 | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck… | Guangzhou Xinbo Electronic Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K063660 | Otc Tens for Low Back Pain Relief, Model WL-2407Summary page 2…Predicate device Information Sponsor: Well Life-Healthcare LTD. Device: OTC TENS for Back Pain Relief, Model WL-2407 5 10(k) No: K063660 3.0 Device Description The Savia OTC TENS Device, Model EM-38 is intended for temporary relief of pain asso… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151693 | Dr-Ho's Foot Pad Electrode | 2015 | 1 |
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 8 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K151693 (Drtv Asia, Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K063660.
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. 2012, 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 intended use of the SAVIA OTC TENS unit Model EM-38 is for the relief of pain associated with sore or aching muscles of the lower back due to strain from exercise or normal household and work activities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113321: Tens Back Pain Relief System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113321
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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