510(k) · Cleared
ClearedEmpi Model 989, Tens
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 15, 1988 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 77 later devices descend from it.
- Decided
- Apr 15, 1988
- Review
- 31 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 0
77 later devices descend from it, 2 citing it directly.
- This deviceK881114 Empi Model 989, TensEmpi · 1988
- 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 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · 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) | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| +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 | 2 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (77)
See all 772 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 | — |
https://510kreport.com/device/K881114 · printed Nov 5, 2026
Cite this page
510(k) Report. “K881114: Empi Model 989, Tens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K881114
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026