510(k) · Cleared
ClearedactiTENS
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 Dec 22, 2020 as substantially equivalent to K182203 (Jkh USA, LLC, 2019) after a 141-day review. Its family tree reaches back 8 generations to 1988. 1 later device descends from it.
- Decided
- Dec 22, 2020
- Review
- 141 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K881114 (1988). 50 ancestors in all, the oldest K872976 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK881114 Empi Model 989, TensEmpi · 1988
- 7 generations backK970203 Epix VTEmpi · 1997
- 6 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 5 generations backK090922 Empi Active Transcutaneous Nerve StimulatorEmpi · 2009
- 4 generations backK121184 SensusNeurometrix, Inc. · 2012
- 3 generations backK130919 SensusNeurometrix, Inc. · 2013
- 2 generations backK140333 AscendNeurometrix, Inc. · 2014
- 1 generation backK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- This deviceK202159 actiTENSSublimed · 2020
- Descendant · cites it directly · 0 of its ownK252767 actiTENS miniSublimed · 2026
Most influential descendants
Showing 1 of 1 · See all- K252767actiTENS miniSublimed · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −7 | K970203 | Epix VT | Empi | 1997 | — |
| −6 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −5 | K090922 | Empi Active Transcutaneous Nerve Stimulator | Empi | 2009 | — |
| −4 | K121184 | Sensus | Neurometrix, Inc. | 2012 | — |
| −3 | K130919 | Sensus | Neurometrix, Inc. | 2013 | — |
| −2 | K140333 | Ascend | Neurometrix, Inc. | 2014 | — |
| −1 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| 0 (this device) | K202159 | actiTENS | Sublimed | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K182203 | JKH Stimulator PlusSummary page 4…, IPF III. PREDICATE DEVICE Predicate Manufacturer: JKH USA, LLC Predicate Trade Name: JKH Stimulator Plus Predicate 510(k): K182203 No reference devices were used in this submission. IV. DEVICE DESCRIPTION actiTENS is a transcutaneous electrical nerve stimula… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252767 | actiTENS mini | 2026 | 0 |
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 32 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 50 ancestors has a recall of any class.
- Of its descendants, K252767 (Sublimed, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K182203.
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. 2020, 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?
actiTENS 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…
Read the full statement (144 words)
actiTENS 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 and P13 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 as stated in the FDA summary.
https://510kreport.com/device/K202159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202159: actiTENS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202159
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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