# K052785: Otc Tens for Low Back Pain Relief, Model WL-2405 and WL-2406

- Pathway: 510(k) (Special)
- Applicant: Well-Life Healthcare Limited
- Decided: Mar 17, 2006 after 165 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: 1 generation back to K040512 (2004). 1 ancestor in all.
8 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040512: Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and WL-2401, Well-Life Healthcare, Inc. (2004) Summary page 1.

## Most influential descendants
- K133723: Otc Patch (2014), 3 descendants of its own
- K063660: Otc Tens for Low Back Pain Relief, Model WL-2407 (2007), 3 descendants of its own
- K113321: Tens Back Pain Relief System (2012), 2 descendants of its own
- K151693: Dr-Ho's Foot Pad Electrode (2015), 1 descendant of its own
- K220524: Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) (2022), 0 descendants of its own

## Indications for use
The model WL-2406 are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K052785
Methodology: https://510kreport.com/methodology