510(k) · Cleared
ClearedFD Tens 2030, Model DFJ24T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fuji Dynamics Limited · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jan 25, 2006 as substantially equivalent to K994266 (Fuji Dynamics Limited, 2000) after a 113-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Jan 25, 2006
- Review
- 113 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K994266 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK994266 Fdtens 2010Fuji Dynamics Limited · 2000
- This deviceK052813 FD Tens 2030, Model DFJ24TFuji Dynamics Limited · 2006
- Descendant · cites it directly · 0 of its ownK152676 FD Tens 2090, FD Tens 2095Fuji Dynamics, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK111654 FD Tens 2070Fuji Dynamics, Ltd. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K994266 | Fdtens 2010 | Fuji Dynamics Limited | 2000 | — |
| 0 (this device) | K052813 | FD Tens 2030, Model DFJ24T | Fuji Dynamics Limited | 2006 | — |
| +1 | K152676 | FD Tens 2090, FD Tens 2095 | Fuji Dynamics, Ltd. | 2016 | — |
| +1 | K111654 | FD Tens 2070 | Fuji Dynamics, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 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 |
|---|---|---|---|
| * | K994266 | Fdtens 2010Summary page 1…(21 CFR 882.5890) Device Classification: Class IL 10.3PredicateDevice Information: The FD TENS 2030 is equivalent to the FDTENS 2010 (K994266). 10.4Device Description: The FD TENS 2030 is a handheld battery powered TENS device, which is used for pain relief. The device… | 2000 |
What descends from it? (2)
2 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?
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 FD TENS 2030 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052813: FD Tens 2030, Model DFJ24T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052813
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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