510(k) · Cleared
ClearedHealy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Timewaver Production GmbH · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Nov 22, 2019 as substantially equivalent to K172079 (Omron Healthcare, Inc., 2017) after a 213-day review. Its family tree reaches back 3 generations to 2013.
- Decided
- Nov 22, 2019
- Review
- 213 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K130802 (2013). No later device cites it as a predicate yet.
- Root · 3 generations backK130802 Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060)Shenzhen Dongdixin Technology Co., Ltd. · 2013
- 2 generations backK151035 PulseReliefPhilips Consumer Lifestyle · 2015
- 1 generation backK172079 AvailOmron Healthcare, Inc. · 2017
- This deviceK191075 HealyTimewaver Production GmbH · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K130802 | Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060) | Shenzhen Dongdixin Technology Co., Ltd. | 2013 | — |
| −2 | K151035 | PulseRelief | Philips Consumer Lifestyle | 2015 | — |
| −1 | K172079 | Avail | Omron Healthcare, Inc. | 2017 | — |
| 0 (this device) | K191075 | Healy | Timewaver Production GmbH | 2019 | — |
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 |
|---|---|---|---|
| * | K172079 | AvailSummary page 5…510(k) Summary: xi9107s Substantial Equivalence Summary Table 1: Substantial Equivalence Comparison Table Microcurrent Microcurrent Comparison 510(k) Number K191075 K172079 Regulation 21 CFR§882.5890 21 CFR§882.5890 No Difference Product Code NUH, NYN NUH Similar, Healy adds product code NYN, howeve… | 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 6 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K172079.
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. 2019, 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?
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities and for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
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/K191075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191075: Healy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191075
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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