510(k) · Cleared
ClearedSelect Tens, Model 4600S
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 Jan 22, 2007 as substantially equivalent to K970203 (Empi, 1997) and 1 other predicate after a 223-day review. Its family tree reaches back 2 generations to 1988. 56 later devices descend from it.
- Decided
- Jan 22, 2007
- Review
- 223 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K881114 (1988). 4 ancestors in all. 56 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK881114 Empi Model 989, TensEmpi · 1988
- 1 generation backK970203 Epix VTEmpi · 1997
- This deviceK061650 Select Tens, Model 4600SEmpi · 2007
- Descendant · cites it directly · 33 of its ownK113037 Pain-AidPdi Works, LLC · 2012
- Descendant · 2 generations on · 32 of its ownK131159 SmartreliefChattem, Inc. · 2013
- Descendant · cites it directly · 26 of its ownK093324 Empi ContinuumEmpi · 2010
- Descendant · 2 generations on · 25 of its ownK124016 Empi PhoenixDjo, LLC · 2013
- Descendant · cites it directly · 24 of its ownK153704 StriveDjo, LLC · 2016
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K113037Pain-AidPdi Works, LLC · 2012 · cites it directly33descendants
- K131159SmartreliefChattem, Inc. · 2013 · 2 generations on32descendants
- K093324Empi ContinuumEmpi · 2010 · cites it directly26descendants
- K124016Empi PhoenixDjo, LLC · 2013 · 2 generations on25descendants
- K153704StriveDjo, LLC · 2016 · cites it directly24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −1 | K970203 | Epix VT | Empi | 1997 | — |
| 0 (this device) | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| +1 | K113037 | Pain-Aid | Pdi Works, LLC | 2012 | — |
| +2 | K131159 | Smartrelief | Chattem, Inc. | 2013 | — |
| +1 | K093324 | Empi Continuum | Empi | 2010 | — |
| +2 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
| +1 | K153704 | Strive | Djo, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 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 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 |
|---|---|---|---|
| * | K970203 | Epix VTSummary page 1…timulator (21 CFR 882.5890, Product Code GZJ) Classification: II Predicate devices: Empi Epix VT® iENS System (K970203), Chattanooga Group Forte CPS 400 Stim and Forte CPS 200 Stim (K982… | 1997 |
| * | K982828 | Forte, Models CPS 400 Stim, CPS 200 StimSummary page 1…Empi Epix VT® iENS System (K970203), Chattanooga Group Forte CPS 400 Stim and Forte CPS 200 Stim (K982828) Device Description: The SELECT® is a portable, dual channel TENS device with ten pre-programmed operational modes. It is powere… | 1998 |
What descends from it? (56)
See all 567 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 19 years and passes through 1 company; a new generation was cleared every 9.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K113037 (Pdi Works, LLC, 2012) has gone furthest, with 33 descendants of its own.
- 4 other devices also cite its predicate K970203.
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. 2007, this device’s year, is highlighted.
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 Empi® SELECT Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. It is also used as an 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/K061650 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061650: Select Tens, Model 4600S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061650
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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