510(k) · Cleared
ClearedEasystim TN28_Otc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Easymed Instruments Co., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Aug 28, 2014 as substantially equivalent to K110068 (Omron Healthcare, Inc., 2011) and 1 other predicate after a 217-day review. Its family tree reaches back 4 generations to 1994. 6 later devices descend from it.
- Decided
- Aug 28, 2014
- Review
- 217 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K940301 (1994). 8 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 3 generations backK011880 Compex SportCompex S.A. · 2002
- 2 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 1 generation backK110068 Model PM3030Omron Healthcare, Inc. · 2011
- This deviceK140168 Easystim TN28_OtcEasymed Instruments Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK183288 Transcutaneous Electrical Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK150043 Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK143430 SmartTENSEasy Med Instrument Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK222867 AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK200237 Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K183288Transcutaneous Electrical Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd. · 2019 · cites it directly1descendant
- K150043Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd. · 2015 · cites it directly1descendant
- K143430SmartTENSEasy Med Instrument Co., Ltd. · 2015 · cites it directly1descendant
- K222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd. · 2022 · 2 generations on0descendants
- K200237Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −3 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −2 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −1 | K110068 | Model PM3030 | Omron Healthcare, Inc. | 2011 | — |
| 0 (this device) | K140168 | Easystim TN28_Otc | Easymed Instruments Co., Ltd. | 2014 | — |
| +1 | K183288 | Transcutaneous Electrical Nerve Stimulator | Shenzhen Kentro Medical Electronics Co., Ltd. | 2019 | — |
| +1 | K150043 | Transcutaneous Electrical Nerve Stimulators (TENS) | Andon Health Co, Ltd. | 2015 | — |
| +1 | K143430 | SmartTENS | Easy Med Instrument Co., Ltd. | 2015 | — |
| +2 | K222867 | AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) | Andon Health Co, Ltd. | 2022 | — |
| +2 | K200237 | Transcutaneous Electronic Nerve Stimulator | Shenzhen Kentro Medical Electronics Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 NUH? 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 NUH device
- #1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 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 |
|---|---|---|---|
| * | K110068 | Model PM3030Summary page 4…ification: Class II PREDICATE DEVICES: Device Name: Model PM3030 Manufacturer: Omron Healthcare, Inc. 510(k) Number: K110068 Product Code: NUH 4 Ad… | 2011 |
| * | K040253 | Easy Med TN-28 CSummary page 5…r the relief of your suffering Device Name: EasyMed TN-28C T.E.N.S. Unit Manufacturer: EasyMed Instrument Co., Ltd 510(k) Number: K040253 Product Code: GZJ INDICATIONS FOR USE: This device is intended for the relief of pain associated with sore or ach… | 2004 |
What descends from it? (6)
3 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?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K183288 (Shenzhen Kentro Medical Electronics Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K110068.
How does its category compare?
All NUH devicesNUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NUH
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUH
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUH
No recall names NUH since 2007.
Adverse event reports per year · NUH
7in 2025
MAUDE reports naming product code NUH, 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 | 4 | 161 | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 148 | 0 | 0 |
| 2011 | 6 | 231 | 0 | 0 |
| 2012 | 6 | 170 | 0 | 0 |
| 2013 | 10 | 189 | 0 | 1 |
| 2014 | 16 | 212 | 0 | 9 |
| 2015 | 14 | 198 | 0 | 11 |
| 2016 | 13 | 145 | 0 | 13 |
| 2017 | 17 | 155 | 0 | 21 |
| 2018 | 16 | 121 | 0 | 18 |
| 2019 | 19 | 213 | 0 | 5 |
| 2020 | 14 | 147 | 0 | 8 |
| 2021 | 14 | 198 | 0 | 7 |
| 2022 | 20 | 103 | 0 | 2 |
| 2023 | 15 | 127 | 0 | 4 |
| 2024 | 20 | 90 | 0 | 7 |
| 2025 | 15 | 119 | 0 | 7 |
| 2026 | 5 | 137 | 0 | — |
What is it indicated for?
EasyStim TN28_OTC is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140168 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140168: Easystim TN28_Otc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140168
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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