510(k) · Cleared
ClearedTenscare Ultima NMS/Ems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tenscare, Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Mar 3, 2003 as substantially equivalent to K020846 (Tenscare, Ltd., 2002) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 2000. 4 later devices descend from it.
- Decided
- Mar 3, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K994266 (2000). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK994266 Fdtens 2010Fuji Dynamics Limited · 2000
- 1 generation backK020846 Ultima Tens XL-A1Tenscare, Ltd. · 2002
- This deviceK023997 Tenscare Ultima NMS/EmsTenscare, Ltd. · 2003
- Descendant · cites it directly · 3 of its ownK050921 Easystim NMS-28Easy Med Instrument Co., Ltd. · 2005
- Descendant · 2 generations on · 2 of its ownK120054 Ultima NeoPain Management Technologies · 2012
- Descendant · 3 generations on · 1 of its ownK232441 Unipro (K-UNIPRO-US)Tenscare, Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK252236 CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025
Most influential descendants
Showing 4 of 4 · See all- K050921Easystim NMS-28Easy Med Instrument Co., Ltd. · 2005 · cites it directly3descendants
- K120054Ultima NeoPain Management Technologies · 2012 · 2 generations on2descendants
- K232441Unipro (K-UNIPRO-US)Tenscare, Ltd. · 2024 · 3 generations on1descendant
- K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K994266 | Fdtens 2010 | Fuji Dynamics Limited | 2000 | — |
| −1 | K020846 | Ultima Tens XL-A1 | Tenscare, Ltd. | 2002 | — |
| 0 (this device) | K023997 | Tenscare Ultima NMS/Ems | Tenscare, Ltd. | 2003 | — |
| +1 | K050921 | Easystim NMS-28 | Easy Med Instrument Co., Ltd. | 2005 | — |
| +2 | K120054 | Ultima Neo | Pain Management Technologies | 2012 | — |
| +3 | K232441 | Unipro (K-UNIPRO-US) | Tenscare, Ltd. | 2024 | — |
| +4 | 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 |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.6 · 25 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.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050921 | Easystim NMS-28 | 2005 | 3 |
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 3 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K050921 (Easy Med Instrument Co., Ltd., 2005) has gone furthest, with 3 descendants of its own.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
TENS is used for the relief and management of symptomatic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post traumatic acute pain.
The Ultima NMS/EMS is indicated for the following;
Relaxation of muscle spasm
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Prevention of venous thrombosis of the calf muscles immediately after surgery
Maintaining or increasing range of motion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023997: Tenscare Ultima NMS/Ems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023997
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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