510(k) · Cleared
ClearedTranscutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Kentro Medical Electronics Co., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on May 10, 2023 as substantially equivalent to K220998 (Shenzhen Kentro Medical Electronics Co., Ltd., 2022) after a 230-day review. Its family tree reaches back 2 generations to 2021.
- Decided
- May 10, 2023
- Review
- 230 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K210825 (2021). No later device cites it as a predicate yet.
- Root · 2 generations backK210825 Revitive Medic Coach (Model Number 5575AQ)Actegy, Ltd. · 2021
- 1 generation backK220998 Transcutaneous Electrical Nerve Stimulator, Model: KTR-405Shenzhen Kentro Medical Electronics Co., Ltd. · 2022
- This deviceK222870 Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031…Shenzhen Kentro Medical Electronics Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K210825 | Revitive Medic Coach (Model Number 5575AQ) | Actegy, Ltd. | 2021 | — |
| −1 | K220998 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 | Shenzhen Kentro Medical Electronics Co., Ltd. | 2022 | — |
| 0 (this device) | K222870 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032… | Shenzhen Kentro Medical Electronics Co., Ltd. | 2023 | — |
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? (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 |
|---|---|---|---|
| * | K220998 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405Summary page 5…ion 8. 510 (k) Summary LTD Device Name and Model Transcutaneous Electrical Nerve Stimulator/ KTR-405 510(k) Number K220998 Product Code NGX, NUH, IPF, NYN, GZJ Regulation Number 21 CFR 890.5850, 882.5890 Regulation Class… | 2022 |
| † | K171381 | Adhesive Electrodes | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 2 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- None of the 2 ancestors has a recall.
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. 2023, 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?
1)When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended: ● for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping ● to temporarily increase local blood circulation…
Read the full statement (235 words)
1)When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended:
● for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping
● to temporarily increase local blood circulation in healthy leg muscles
● to stimulate healthy muscles in order to improve and facilitate muscle performance
● to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities(legs) due to strain from exercise or normal household duties
● to relax muscle spasm
● to increase blood flow circulation
● for prevention of retardation of disuse atrophy
● for muscle re-education
● for maintaining or increasing range of motion
● Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
● Provide quadricep strengthening
● Improve knee stability secondary to quadricep strengthening
2) When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide:
● symptomatic relief and management of chronic, intractable pain
● relief of pain associated with arthritis
● temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222870 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222870: Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222870
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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