# K063660: Otc Tens for Low Back Pain Relief, Model WL-2407

- Pathway: 510(k) (Special)
- Applicant: Well-Life Healthcare Limited
- Decided: Feb 7, 2007 after 61 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: 2 generations back to K040512 (2004). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 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.
- K052785: Otc Tens for Low Back Pain Relief, Model WL-2405 and WL-2406, Well-Life Healthcare Limited (2006) Summary page 1.

## Most influential descendants
- 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
- K172887: XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) (2018), 0 descendants of its own

## Indications for use
The model WL-2407 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/K063660
Methodology: https://510kreport.com/methodology