# K133723: Otc Patch

- Pathway: 510(k) (Abbreviated)
- Applicant: Well-Life Healthcare Limited
- Decided: Jan 28, 2014 after 53 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- 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: 5 generations back to K945676 (1995). 18 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052785: Otc Tens for Low Back Pain Relief, Model WL-2405 and WL-2406, Well-Life Healthcare Limited (2006) Summary page 1.
- K091757: Otc Tens for Arm and Leg Pain Relief, Model WL-2407, Well-Life Healthcare Limited (2010) Summary page 1.
- K082065: Well Life Self Adhesive Electrode / Models: CM, FA, PU and SP, Well-Life Healthcare Limited (2009) Summary page 1.

## Most influential descendants
- K220524: Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) (2022), 0 descendants of its own
- K151479: EV-820 OTC Pain Relief TENS (2015), 0 descendants of its own
- K150681: Gemore Otc Tens (2015), 0 descendants of its own

## Indications for use
The OTC Patch, Model WL-2406, is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities

Source page: https://510kreport.com/device/K133723
Methodology: https://510kreport.com/methodology