# K151479: EV-820 OTC Pain Relief TENS

- Pathway: 510(k) (Traditional)
- Applicant: Everyway Medical Instruments Co.,Ltd
- Decided: Oct 16, 2015 after 136 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: 6 generations back to K945676 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133723: Otc Patch, Well-Life Healthcare Limited (2014) Summary page 4.
- K091757: Otc Tens for Arm and Leg Pain Relief, Model WL-2407, Well-Life Healthcare Limited (2010) Summary page 4.

## Indications for use
The Everyway EV-820 OTC Pain Relief TENS 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/K151479
Methodology: https://510kreport.com/methodology