510(k) · Cleared
ClearedUnipro (K-UNIPRO-US)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tenscare, Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Aug 30, 2024 as substantially equivalent to K120054 (Pain Management Technologies, 2012) after a 382-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Aug 30, 2024
- Review
- 382 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K994266 (2000). 15 ancestors in all, the oldest K921441 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK994266 Fdtens 2010Fuji Dynamics Limited · 2000
- 4 generations backK020846 Ultima Tens XL-A1Tenscare, Ltd. · 2002
- 3 generations backK023997 Tenscare Ultima NMS/EmsTenscare, Ltd. · 2003
- 2 generations backK050921 Easystim NMS-28Easy Med Instrument Co., Ltd. · 2005
- 1 generation backK120054 Ultima NeoPain Management Technologies · 2012
- This deviceK232441 Unipro (K-UNIPRO-US)Tenscare, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK252236 CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K994266 | Fdtens 2010 | Fuji Dynamics Limited | 2000 | — |
| −4 | K020846 | Ultima Tens XL-A1 | Tenscare, Ltd. | 2002 | — |
| −3 | K023997 | Tenscare Ultima NMS/Ems | Tenscare, Ltd. | 2003 | — |
| −2 | K050921 | Easystim NMS-28 | Easy Med Instrument Co., Ltd. | 2005 | — |
| −1 | K120054 | Ultima Neo | Pain Management Technologies | 2012 | — |
| 0 (this device) | K232441 | Unipro (K-UNIPRO-US) | Tenscare, Ltd. | 2024 | — |
| +1 | K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K120054 | Ultima NeoSummary page 6…edicate Device Manufacturer : EasyMed Instruments Co., Ltd Trade/Device Name : Ultima NEO 510(k) Number : K120054 Device Classification Name : Stimulator, Nerve, Transcutaneous, for pain relief Regulation Description : Tr… | 2012 |
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 |
|---|---|---|---|
| K252236 | CP Relief Wand Rx - TENS/NMES | 2025 | 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 24 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K252236 (N & C Holdings, LLC, 2025) has gone furthest, with 0 descendants of its own.
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. 2024, 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?
TENS stands for Transcutaneous Electrical Nerve Stimulation. Unipro TENS is used to provide symptomatic pain relief for chronic, acute or post-operative pain. EMS stands for Electrical Neuromuscular Stimulation. Unipro EMS is indicated for: » Relaxation of muscle spasm * Increasing local blood circulation and muscle re-education * Prevention or retardation of disuse atrophy * Prevention of venous thrombosis of the calf muscles immediately after surgery *…
Read the full statement (113 words)
TENS stands for Transcutaneous Electrical Nerve Stimulation. Unipro TENS is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
EMS stands for Electrical Neuromuscular Stimulation. Unipro EMS is indicated for:
» Relaxation of muscle spasm
* Increasing local blood circulation and muscle re-education
* Prevention or retardation of disuse atrophy
* Prevention of venous thrombosis of the calf muscles immediately after surgery
* Maintaining on increasing range of motion
MIC stands for Microcurrent Stimulation. Unipro MIC is used to provide sumptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.
IFT stands for Interferntial Stimulation. Unipro IFT is indicated for symptomatic relief of chronic intractable 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/K232441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232441: Unipro (K-UNIPRO-US).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232441
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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