510(k) · Cleared
ClearedWitouch Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollywog, LLC · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Aug 16, 2012 as substantially equivalent to K061650 (Empi, 2007) and 1 other predicate after a 190-day review. Its family tree reaches back 3 generations to 1988. 3 later devices descend from it.
- Decided
- Aug 16, 2012
- Review
- 190 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K881114 (1988). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK881114 Empi Model 989, TensEmpi · 1988
- 2 generations backK970203 Epix VTEmpi · 1997
- 1 generation backK061650 Select Tens, Model 4600SEmpi · 2007
- This deviceK120398 Witouch ProHollywog, LLC · 2012
- Descendant · cites it directly · 1 of its ownK143430 SmartTENSEasy Med Instrument Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK190009 Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited · 2019
- Descendant · cites it directly · 0 of its ownK171599 WiTouch Pro, WiTouch, NeubacHollywog, LLC · 2017
Most influential descendants
Showing 3 of 3 · See all- K143430SmartTENSEasy Med Instrument Co., Ltd. · 2015 · cites it directly1descendant
- K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited · 2019 · 2 generations on0descendants
- K171599WiTouch Pro, WiTouch, NeubacHollywog, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −2 | K970203 | Epix VT | Empi | 1997 | — |
| −1 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| 0 (this device) | K120398 | Witouch Pro | Hollywog, LLC | 2012 | — |
| +1 | K143430 | SmartTENS | Easy Med Instrument Co., Ltd. | 2015 | — |
| +2 | K190009 | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) | Hong Qiangxing (Shenzhen) Electronics Limited | 2019 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 GZJ? 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 GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K061650 | Select Tens, Model 4600SSummary page 3…physical properties of the WiTouch Pro device and the referenced predicate devices: 510(k) Number K120398 K061650 K(061516 Device Name and Model WiTouch'M Pro EmpiO Select… | 2007 |
| * | K061516 | Staodyn Max Preset, Model 4470Summary page 2…Trade Name _______________________________ K061.650 Empi SELECT" CFR Title 21, Sec. 882.5890, Class 11, GZJ, NYN K061516 Staodyn' Max Preset TENS CER Title 2 1, Sec. 882.5 890, Class 11, GZJ, NYN The predicate devices utilize flexible w… | 2007 |
What descends from it? (3)
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?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K143430 (Easy Med Instrument Co., Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K061650.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, 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 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The WiTouch® Pro Transcutaneous Electrical Nerve Stimulator Device is used
for the symptomatic relief and management of chronic intractable back pain and
relief of pain of the upper and lower back associated with arthritis. It is also used
for adjunctive treatment for post-surgical and post-trauma acute back pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120398 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120398: Witouch Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120398
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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