510(k) · Cleared
ClearedactiTENS mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sublimed · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jan 16, 2026 as substantially equivalent to K202159 (Sublimed, 2020) and 1 other predicate after a 140-day review. Its family tree reaches back 9 generations to 1988.
- Decided
- Jan 16, 2026
- Review
- 140 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K881114 (1988). 51 ancestors in all, the oldest K872976 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK881114 Empi Model 989, TensEmpi · 1988
- 5 generations between
- 3 generations backK140333 AscendNeurometrix, Inc. · 2014
- 2 generations backK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- 1 generation backK202159 actiTENSSublimed · 2020
- This deviceK252767 actiTENS miniSublimed · 2026
Show all 9 generations
- Root · 9 generations backK881114 Empi Model 989, TensEmpi · 1988
- 8 generations backK970203 Epix VTEmpi · 1997
- 7 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 6 generations backK090922 Empi Active Transcutaneous Nerve StimulatorEmpi · 2009
- 5 generations backK121184 SensusNeurometrix, Inc. · 2012
- 4 generations backK130919 SensusNeurometrix, Inc. · 2013
- 3 generations backK140333 AscendNeurometrix, Inc. · 2014
- 2 generations backK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- 1 generation backK202159 actiTENSSublimed · 2020
- This deviceK252767 actiTENS miniSublimed · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −8 | K970203 | Epix VT | Empi | 1997 | — |
| −7 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −6 | K090922 | Empi Active Transcutaneous Nerve Stimulator | Empi | 2009 | — |
| −5 | K121184 | Sensus | Neurometrix, Inc. | 2012 | — |
| −4 | K130919 | Sensus | Neurometrix, Inc. | 2013 | — |
| −3 | K140333 | Ascend | Neurometrix, Inc. | 2014 | — |
| −2 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| −1 | K202159 | actiTENS | Sublimed | 2020 | — |
| 0 (this device) | K252767 | actiTENS mini | Sublimed | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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 K252712 STIMPOD NMS460 Nerve Stimulatorscore 12.6 · 5 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 |
|---|---|---|---|
| * | K202159 | actiTENSSummary page 6…es: NYN, IPF, NGX, NUH III. IDENTIFICATION OF THE PREDICATE Primary Predicate Predicate Manufacturer: Sublimed Predicate Trade Name: actiTENS Predicate 510(k): K202159 Secondary Predicate Predicate Manufacturer: JKH USA, LLC Predicate Trade Name: JKH Stimulator Plus Predicate 510… | 2020 |
| * | K182203 | JKH Stimulator PlusSummary page 6…510(k): K202159 Secondary Predicate Predicate Manufacturer: JKH USA, LLC Predicate Trade Name: JKH Stimulator Plus Predicate 510(k): K182203 No reference devices were used in this submission. 510(k) Summary… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 38 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 51 ancestors has a recall of any class.
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. 2026, 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?
Over-the-counter use : actiTENS Mini is intended to be used as: Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications: -Symptomatic relief and management of chronic, intractable pain -Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities -Relief of pain associated with arthritis Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15…
Read the full statement (211 words)
Over-the-counter use :
actiTENS Mini is intended to be used as:
Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:
-Symptomatic relief and management of chronic, intractable pain
-Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
-Relief of pain associated with arthritis
Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode.
Prescription use:
actiTENS Mini is intended to be used as:
Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:
-Symptomatic relief and management of chronic, intractable pain
-Adjunctive treatment for post-surgical and post-trauma acute pain
-Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
-Relief of pain associated with arthritis
Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode.
Electrical Muscle Stimulation (EMS), used for the following indications:
-Temporary relaxation of muscle spasms
-Prevent or retard disuse atrophy
-Increase of local blood flow in the treatment area
-Re-educate muscles
-Maintain or increase the range of motion
-Prevention of venous thrombosis of the calf muscles immediately after surgery
Program P9 corresponds to EMS mode.
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/K252767 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252767: actiTENS mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252767
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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