510(k) · Cleared
ClearedWiTouch Pro, WiTouch, Neubac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollywog, LLC · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Sep 22, 2017 as substantially equivalent to K120398 (Hollywog, LLC, 2012) after a 113-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Sep 22, 2017
- Review
- 113 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K881114 (1988). 8 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −3 | K970203 | Epix VT | Empi | 1997 | — |
| −2 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −1 | K120398 | Witouch Pro | Hollywog, LLC | 2012 | — |
| 0 (this device) | K171599 | WiTouch Pro, WiTouch, Neubac | Hollywog, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K120398 | Witouch ProSummary page 4…Stimulator, Electrical, Transcutaneous, For Arthritis PREDICATE DEVICE: WiTouch Pro K120398 5-1 Traditional 510(k) Premarket Notification… | 2012 |
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 29 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K120398.
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. 2017, 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 back due to strain from exercise or normal household and work activities and relief of pain of the upper and lower back associated with arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171599: WiTouch Pro, WiTouch, Neubac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171599
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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