510(k) · Cleared
ClearedEasystim NMS-28
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Easy Med Instrument Co., Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Dec 12, 2005 as substantially equivalent to K040253 (Easy Med Instrument Co., Ltd., 2004) and 1 other predicate after a 243-day review. Its family tree reaches back 3 generations to 2000. 3 later devices descend from it.
- Decided
- Dec 12, 2005
- Review
- 243 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K994266 (2000). 5 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK994266 Fdtens 2010Fuji Dynamics Limited · 2000
- 2 generations backK020846 Ultima Tens XL-A1Tenscare, Ltd. · 2002
- 1 generation backK023997 Tenscare Ultima NMS/EmsTenscare, Ltd. · 2003
- This deviceK050921 Easystim NMS-28Easy Med Instrument Co., Ltd. · 2005
- Descendant · cites it directly · 2 of its ownK120054 Ultima NeoPain Management Technologies · 2012
- Descendant · 2 generations on · 1 of its ownK232441 Unipro (K-UNIPRO-US)Tenscare, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK252236 CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K994266 | Fdtens 2010 | Fuji Dynamics Limited | 2000 | — |
| −2 | K020846 | Ultima Tens XL-A1 | Tenscare, Ltd. | 2002 | — |
| −1 | K023997 | Tenscare Ultima NMS/Ems | Tenscare, Ltd. | 2003 | — |
| 0 (this device) | K050921 | Easystim NMS-28 | Easy Med Instrument Co., Ltd. | 2005 | — |
| +1 | K120054 | Ultima Neo | Pain Management Technologies | 2012 | — |
| +2 | K232441 | Unipro (K-UNIPRO-US) | Tenscare, Ltd. | 2024 | — |
| +3 | 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 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 19.7 · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040253 | Easy Med TN-28 CSummary page 2…0 Device Classification: For both FENS & EMS functions - Class II Predicate Device: For the TENS function EasyMed TENS Unit TN-28C (K040253) For the EMS function TensCare Ultima NMS/EMS Model XL-A3 - (K023997) The… | 2004 |
| * | K023997 | Tenscare Ultima NMS/EmsSummary page 2…EasyMed TENS Unit TN-28C (K040253) For the EMS function TensCare Ultima NMS/EMS Model XL-A3 - (K023997) The class of the predicate Device: Class II Device Description: For the TENS function… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120054 | Ultima Neo | 2012 | 2 |
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 5 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K120054 (Pain Management Technologies, 2012) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K040253.
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 stands for Transcutaneous Electrical Nerve Stimulation. This TENS system is used to provide symptomatic pain relief for chronic, acute or post operative pain
PMS/EMS stands for Powered Muscles Stimulator/Electrical Muscles Stimulator. This PMS/EMS system is indicated for:
* Relaxation of muscle spasm
• Increasing local blood circulation
* 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050921: Easystim NMS-28.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050921
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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