510(k) · Cleared
ClearedT1040 Aka Aurawave
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endurance Therapeutics · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Jul 19, 2013 after a 200-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jul 19, 2013
- Review
- 200 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK124055 T1040 Aka AurawaveEndurance Therapeutics · 2013
- Descendant · cites it directly · 3 of its ownK150277 Pain Therapy System, Model PTS-IICounter Scientific Development (Gz), Ltd. · 2016
- Descendant · 2 generations on · 2 of its ownK163611 Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK230443 TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)Jiangxi Royall Smart Technology Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK200237 Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK170205 Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203Shenzhen Kentro Medical Electronics Co., Ltd. · 2017
Most influential descendants
Showing 5 of 5 · See all- K150277Pain Therapy System, Model PTS-IICounter Scientific Development (Gz), Ltd. · 2016 · cites it directly3descendants
- K163611Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd. · 2017 · 2 generations on2descendants
- K230443TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)Jiangxi Royall Smart Technology Co., Ltd. · 2023 · 3 generations on0descendants
- K200237Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd. · 2020 · 3 generations on0descendants
- K170205Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203Shenzhen Kentro Medical Electronics Co., Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K124055 | T1040 Aka Aurawave | Endurance Therapeutics | 2013 | — |
| +1 | K150277 | Pain Therapy System, Model PTS-II | Counter Scientific Development (Gz), Ltd. | 2016 | — |
| +2 | K163611 | Pain Therapy Device | Guangzhou Xinbo Electronic Co., Ltd. | 2017 | — |
| +3 | K230443 | TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) | Jiangxi Royall Smart Technology Co., Ltd. | 2023 | — |
| +3 | K200237 | Transcutaneous Electronic Nerve Stimulator | Shenzhen Kentro Medical Electronics Co., Ltd. | 2020 | — |
| +1 | K170205 | Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 | Shenzhen Kentro Medical Electronics Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
2 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?
- Of its descendants, K150277 (Counter Scientific Development (Gz), Ltd., 2016) has gone furthest, with 3 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. 2013, 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?
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities choose Manual modes 1,2, 3,4, 5, 6 or Auto 4. To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes 1,2, 3,4, 5, 6 or Auto 1 or Auto 3.. To be…
Read the full statement (176 words)
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities choose Manual modes 1,2, 3,4, 5, 6 or Auto 4.
To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes 1,2, 3,4, 5, 6 or Auto 1 or Auto 3..
To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes 1,2, 6 or Autol or Auto 4.
To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, choose Manual modes 1 and 3 or Auto 1,Auto 2, Auto 3, or Auto 4.
Used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode 1 or Auto Mode 2.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K124055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124055: T1040 Aka Aurawave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124055
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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