# K110716: Everyway Low Back Pain Relief System

- Pathway: 510(k) (Traditional)
- Applicant: Everyway Medical Instruments Co.,Ltd
- Decided: Oct 18, 2011 after 217 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.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060222: Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PP, Gemore Technology Co, Ltd. (2006) Summary page 1.

## Indications for use
The Everyway Low Back Pain Relief System, model EV-820 is indicated for over the counter use in the temporary relief of pain associated with sore and aching muscles in the low back due to strain from exercise or normal household and work activities

Source page: https://510kreport.com/device/K110716
Methodology: https://510kreport.com/methodology