510(k) · Cleared
ClearedTranscutaneous Electrical Nerve Stimulator, Model: KTR-405
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 Aug 24, 2022 as substantially equivalent to K210825 (Actegy, Ltd., 2021) after a 142-day review. Its family tree reaches back 1 generation to 2021. 1 later device descends from it.
- Decided
- Aug 24, 2022
- Review
- 142 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K210825 (2021). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK210825 Revitive Medic Coach (Model Number 5575AQ)Actegy, Ltd. · 2021
- This deviceK220998 Transcutaneous Electrical Nerve Stimulator, Model: KTR-405Shenzhen Kentro Medical Electronics Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK222870 Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031…Shenzhen Kentro Medical Electronics Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222870Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012…Shenzhen Kentro Medical Electronics Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K210825 | Revitive Medic Coach (Model Number 5575AQ) | Actegy, Ltd. | 2021 | — |
| 0 (this device) | K220998 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 | Shenzhen Kentro Medical Electronics Co., Ltd. | 2022 | — |
| +1 | K222870 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032… | Shenzhen Kentro Medical Electronics Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K210825 | Revitive Medic Coach (Model Number 5575AQ)Summary page 5…Page 1 of 8 SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD 510 (k) Summary 510(k) Number K210825 Product Code NGX, NUH, IPF, NYN, GZJ Regulation Number 21 CFR 890.5850, 882.5890 Regulation Class… | 2021 |
| † | K171381 | Adhesive Electrodes | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222870 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012… | 2023 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K222870 (Shenzhen Kentro Medical Electronics Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
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. 2022, 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 in…
Read the full statement (221 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220998 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220998: Transcutaneous Electrical Nerve Stimulator, Model: KTR-405.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220998
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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