510(k) · Cleared
ClearedUltima Neo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pain Management Technologies · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jun 5, 2012 as substantially equivalent to K050921 (Easy Med Instrument Co., Ltd., 2005) and 2 other predicates after a 151-day review. Its family tree reaches back 4 generations to 2000. 2 later devices descend from it.
- Decided
- Jun 5, 2012
- Review
- 151 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K994266 (2000). 14 ancestors in all, the oldest K921441 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK994266 Fdtens 2010Fuji Dynamics Limited · 2000
- 3 generations backK020846 Ultima Tens XL-A1Tenscare, Ltd. · 2002
- 2 generations backK023997 Tenscare Ultima NMS/EmsTenscare, Ltd. · 2003
- 1 generation backK050921 Easystim NMS-28Easy Med Instrument Co., Ltd. · 2005
- This deviceK120054 Ultima NeoPain Management Technologies · 2012
- Descendant · cites it directly · 1 of its ownK232441 Unipro (K-UNIPRO-US)Tenscare, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK252236 CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025
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 |
|---|---|---|---|---|---|
| −4 | K994266 | Fdtens 2010 | Fuji Dynamics Limited | 2000 | — |
| −3 | K020846 | Ultima Tens XL-A1 | Tenscare, Ltd. | 2002 | — |
| −2 | K023997 | Tenscare Ultima NMS/Ems | Tenscare, Ltd. | 2003 | — |
| −1 | K050921 | Easystim NMS-28 | Easy Med Instrument Co., Ltd. | 2005 | — |
| 0 (this device) | K120054 | Ultima Neo | Pain Management Technologies | 2012 | — |
| +1 | K232441 | Unipro (K-UNIPRO-US) | Tenscare, Ltd. | 2024 | — |
| +2 | 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 |
|---|---|---|
| 2024 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K050921 | Easystim NMS-28Summary page 2…rential current therapy - LIH Device Classification: For EMS, TENS / MIC and IF systems - Class 11 Predicate Devices: EasyMed EMS/TENS Model NMS-28 (K050921); MT9000 Combo TENS/EMS/IF/MIC (K093138)/(Trade name: InTENSity TM Select Combo) ;… | 2005 |
| * | K093138 | MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003Summary page 2…ation: For EMS, TENS / MIC and IF systems - Class 11 Predicate Devices: EasyMed EMS/TENS Model NMS-28 (K050921); MT9000 Combo TENS/EMS/IF/MIC (K093138)/(Trade name: InTENSity TM Select Combo) ; GM3 Series IF TENS Model GM3X2IF (K032719)… | 2010 |
| * | K032719 | GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of Different Housing)Summary page 2…MT9000 Combo TENS/EMS/IF/MIC (K093138)/(Trade name: InTENSity TM Select Combo) ; GM3 Series IF TENS Model GM3X2IF (K032719) The class of the predicate Devices: Class 11 Device Description: A portable TENS/EMS/MIC/IF combo de… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232441 | Unipro (K-UNIPRO-US) | 2024 | 1 |
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 12 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K232441 (Tenscare, Ltd., 2024) has gone furthest, with 1 descendant 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. 2012, 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. The Ultima NEO TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain. EMS stands for Electrical Neuromuscular Stimulator. The Ultima NEO EMS system 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…
Read the full statement (120 words)
TENS stands for Transcutaneous Electrical Nerve Stimulation. The Ultima NEO TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
EMS stands for Electrical Neuromuscular Stimulator. The Ultima NEO EMS system 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 or increasing range of motion.
MIC stands for Microcurrent Stimulation. The Ultima NEO MIC system is used to provide symptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.
IF stands for Interferential Stimulation. The Ultima NEO IF system is indicated for:
*Symptomatic relief of chronic intractable pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120054 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120054: Ultima Neo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120054
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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