510(k) · Cleared
ClearedEasy Med TN-28 C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Easy Med Instrument Co., Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Apr 8, 2004 as substantially equivalent to K994266 (Fuji Dynamics Limited, 2000) after a 64-day review. Its family tree reaches back 1 generation to 2000. 13 later devices descend from it.
- Decided
- Apr 8, 2004
- Review
- 64 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K994266 (2000). 13 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK994266 Fdtens 2010Fuji Dynamics Limited · 2000
- This deviceK040253 Easy Med TN-28 CEasy Med Instrument Co., Ltd. · 2004
- Descendant · cites it directly · 6 of its ownK140168 Easystim TN28_OtcEasymed Instruments Co., Ltd. · 2014
- 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 · 2 generations on · 1 of its ownK183288 Transcutaneous Electrical Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd. · 2019
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K140168Easystim TN28_OtcEasymed Instruments Co., Ltd. · 2014 · cites it directly6descendants
- 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
- K183288Transcutaneous Electrical Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd. · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K994266 | Fdtens 2010 | Fuji Dynamics Limited | 2000 | — |
| 0 (this device) | K040253 | Easy Med TN-28 C | Easy Med Instrument Co., Ltd. | 2004 | — |
| +1 | K140168 | Easystim TN28_Otc | Easymed Instruments Co., Ltd. | 2014 | — |
| +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 | — |
| +2 | K183288 | Transcutaneous Electrical Nerve Stimulator | Shenzhen Kentro Medical Electronics Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K994266 | Fdtens 2010Summary page 1…ectrical Nerve Stimulator (T.E.N.S) Identification of the legally marketed device The legally marketed device which EasyMed is claiming equivalence: 510(k) No: K994266 Device name: FDTENS 2010 Manufacturer: Fuji Dynamics Ltd The TN-28C TENS Unit is SE to the FDTENS 2010, their circuit… | 2000 |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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.
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?
T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. This T.E.N.S. system is used to provide symptomatic pain relief for chronic, acute or post operative pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040253: Easy Med TN-28 C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040253
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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