510(k) · Cleared
ClearedEpix XL Tens Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Empi · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Mar 20, 1996 after a 331-day review. The FDA summary names its predicate without a number. 76 later devices descend from it.
- Decided
- Mar 20, 1996
- Review
- 331 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 0
76 later devices descend from it, 3 citing it directly.
- This deviceK951903 Epix XL Tens UnitEmpi · 1996
- Descendant · cites it directly · 75 of its ownK970203 Epix VTEmpi · 1997
- Descendant · 2 generations on · 56 of its ownK061650 Select Tens, Model 4600SEmpi · 2007
- Descendant · 3 generations on · 33 of its ownK113037 Pain-AidPdi Works, LLC · 2012
- Descendant · 4 generations on · 32 of its ownK131159 SmartreliefChattem, Inc. · 2013
- Descendant · 3 generations on · 26 of its ownK093324 Empi ContinuumEmpi · 2010
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K970203Epix VTEmpi · 1997 · cites it directly75descendants
- K061650Select Tens, Model 4600SEmpi · 2007 · 2 generations on56descendants
- K113037Pain-AidPdi Works, LLC · 2012 · 3 generations on33descendants
- K131159SmartreliefChattem, Inc. · 2013 · 4 generations on32descendants
- K093324Empi ContinuumEmpi · 2010 · 3 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951903 | Epix XL Tens Unit | Empi | 1996 | — |
| +1 | K970203 | Epix VT | Empi | 1997 | — |
| +2 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| +3 | K113037 | Pain-Aid | Pdi Works, LLC | 2012 | — |
| +4 | K131159 | Smartrelief | Chattem, Inc. | 2013 | — |
| +3 | K093324 | Empi Continuum | Empi | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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 GZJ? 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 GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 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 |
|---|---|---|---|
| * | — | Empi Epix XL Model 989 Named without a submission number |
What descends from it? (76)
See all 763 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?
- Of its descendants, K970203 (Empi, 1997) has gone furthest, with 75 descendants of its own.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, 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 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Epix XL TENS Unit is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.
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/K951903 · printed Nov 4, 2026
Cite this page
510(k) Report. “K951903: Epix XL Tens Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951903
Report an extraction error
Are you the manufacturer?
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