# K172919: EV-804 OTC Pain Relief TENS

- Pathway: 510(k) (Traditional)
- Applicant: Everyway Medical Instruments Co.,Ltd
- Decided: Apr 19, 2018 after 206 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K181207: Balego TENS Digital Edition with Accessories for Pain Relief (OTC) (2018), 0 descendants of its own

## Indications for use
The OTC Pain Relief TENS, model EV-804, 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/K172919
Methodology: https://510kreport.com/methodology