# K113321: Tens Back Pain Relief System

- Pathway: 510(k) (Traditional)
- Applicant: Savia Limited
- Decided: Sep 4, 2012 after 299 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: 3 generations back to K040512 (2004). 3 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K063660: Otc Tens for Low Back Pain Relief, Model WL-2407, Well-Life Healthcare Limited (2007) Summary page 2.

## Most influential descendants
- 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 intended use of the SAVIA OTC TENS unit Model EM-38 is for the relief of pain associated with sore or aching muscles of the lower back due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K113321
Methodology: https://510kreport.com/methodology