510(k) · Cleared
ClearedEpix VT
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 Apr 14, 1997 as substantially equivalent to K881114 (Empi, 1988) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1988. 75 later devices descend from it.
- Decided
- Apr 14, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K881114 (1988). 2 ancestors in all. 75 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK881114 Empi Model 989, TensEmpi · 1988
- This deviceK970203 Epix VTEmpi · 1997
- Descendant · cites it directly · 56 of its ownK061650 Select Tens, Model 4600SEmpi · 2007
- Descendant · 2 generations on · 33 of its ownK113037 Pain-AidPdi Works, LLC · 2012
- Descendant · 3 generations on · 32 of its ownK131159 SmartreliefChattem, Inc. · 2013
- Descendant · 2 generations on · 26 of its ownK093324 Empi ContinuumEmpi · 2010
- Descendant · 3 generations on · 25 of its ownK124016 Empi PhoenixDjo, LLC · 2013
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K061650Select Tens, Model 4600SEmpi · 2007 · cites it directly56descendants
- K113037Pain-AidPdi Works, LLC · 2012 · 2 generations on33descendants
- K131159SmartreliefChattem, Inc. · 2013 · 3 generations on32descendants
- K093324Empi ContinuumEmpi · 2010 · 2 generations on26descendants
- K124016Empi PhoenixDjo, LLC · 2013 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| 0 (this device) | K970203 | Epix VT | Empi | 1997 | — |
| +1 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| +2 | K113037 | Pain-Aid | Pdi Works, LLC | 2012 | — |
| +3 | K131159 | Smartrelief | Chattem, Inc. | 2013 | — |
| +2 | K093324 | Empi Continuum | Empi | 2010 | — |
| +3 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K881114 | Empi Model 989, TensSummary page 1…Classification Name: Transcutaneous Electrical Nerve Stimulator (TENS) per 21 CFR 882.5890 Common/Usual Name: TENS System ~ Predicate Device: Empi Epix® XL TENS System (K881114 and K951503) Device Description The Epix® VT is a dual channel TENS device with twelve pre-programmed output modes. It is powere… | 1988 |
| * | K951903 | Epix XL Tens Unit Our OCR of the scanned summary read K951503, FDA’s number for CVD Bullett HI-Flo Infusion Catheter (Cardiovascular Dynamics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Empi Epix® XL TENS System”. | 1996 |
What descends from it? (75)
See all 755 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061650 | Select Tens, Model 4600S | 2007 | 56 |
| K011702 | Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx | 2001 | 14 |
| K022241 | Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXX | 2002 | 13 |
| K032928 | Mediphysics Pain Treatment System, Model 1 | 2003 | 2 |
| K070474 | Newlife Sciences LLC, Model TMR | 2007 | 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?
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® VT 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/K970203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970203: Epix VT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970203
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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