# K120398: Witouch Pro

- Pathway: 510(k) (Traditional)
- Applicant: Hollywog, LLC
- Decided: Aug 16, 2012 after 190 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K881114 (1988). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061650: Select Tens, Model 4600S, Empi (2007) Summary page 3.
- K061516: Staodyn Max Preset, Model 4470, Compex Technologies, Inc. (2007) Summary page 2.

## Most influential descendants
- K143430: SmartTENS (2015), 1 descendant of its own
- K190009: Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) (2019), 0 descendants of its own
- K171599: WiTouch Pro, WiTouch, Neubac (2017), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K120398
Methodology: https://510kreport.com/methodology