510(k) · Cleared
ClearedStrive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Djo, LLC · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jun 3, 2016 as substantially equivalent to K061650 (Empi, 2007) and 2 other predicates after a 163-day review. Its family tree reaches back 5 generations to 1988. 24 later devices descend from it.
- Decided
- Jun 3, 2016
- Review
- 163 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K881114 (1988). 27 ancestors in all, the oldest K872976 (1987). 24 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK881114 Empi Model 989, TensEmpi · 1988
- 4 generations backK970203 Epix VTEmpi · 1997
- 3 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 2 generations backK093324 Empi ContinuumEmpi · 2010
- 1 generation backK124016 Empi PhoenixDjo, LLC · 2013
- This deviceK153704 StriveDjo, LLC · 2016
- Descendant · cites it directly · 10 of its ownK170903 Compex Wireless USADjo, LLC · 2017
- Descendant · cites it directly · 7 of its ownK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 2 generations on · 4 of its ownK191151 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · cites it directly · 4 of its ownK170918 Compex Sport EliteDjo, LLC · 2017
- Descendant · 2 generations on · 3 of its ownK190966 Katalyst Training SystemKatalyst, Inc. · 2020
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K170903Compex Wireless USADjo, LLC · 2017 · cites it directly10descendants
- K182203JKH Stimulator PlusJkh USA, LLC · 2019 · cites it directly7descendants
- K191151JKH Stimulator PlusJkh USA, LLC · 2019 · 2 generations on4descendants
- K170918Compex Sport EliteDjo, LLC · 2017 · cites it directly4descendants
- K190966Katalyst Training SystemKatalyst, Inc. · 2020 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −4 | K970203 | Epix VT | Empi | 1997 | — |
| −3 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −2 | K093324 | Empi Continuum | Empi | 2010 | — |
| −1 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
| 0 (this device) | K153704 | Strive | Djo, LLC | 2016 | — |
| +1 | K170903 | Compex Wireless USA | Djo, LLC | 2017 | — |
| +1 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +2 | K191151 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +1 | K170918 | Compex Sport Elite | Djo, LLC | 2017 | — |
| +2 | K190966 | Katalyst Training System | Katalyst, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K061650 | Select Tens, Model 4600SSummary page 5…NUH (primary code) NYN (subsequent code) Regulatory Class: Class II Predicate Device: EMPI Select (K061650) EMPI Phoenix (K124016) SmartRelief (K131159) Device Description:… | 2007 |
| * | K124016 | Empi PhoenixSummary page 5…NYN (subsequent code) Regulatory Class: Class II Predicate Device: EMPI Select (K061650) EMPI Phoenix (K124016) SmartRelief (K131159) Device Description: The Strive device is a handheld Transcutaneous Elec… | 2013 |
| * | K131159 | SmartreliefSummary page 5…Class II Predicate Device: EMPI Select (K061650) EMPI Phoenix (K124016) SmartRelief (K131159) Device Description: The Strive device is a handheld Transcutaneous Electrical Nerve Stimulation (TENS) unit which delivers… | 2013 |
What descends from it? (24)
See all 243 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 28 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K170903 (Djo, LLC, 2017) has gone furthest, with 10 descendants of its own.
- 6 other devices also cite its predicate K061650.
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. 2016, 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 Strive™ TENS 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. As a TENS device, indications are for the following conditions: - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Relief of pain…
Read the full statement (116 words)
The Strive™ TENS 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.
As a TENS device, indications are for the following conditions:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
The Strive™ TENS device is used for:
-temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
-the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153704: Strive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153704
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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