# K222488: Everyway Analog OTC TENS

- Pathway: 510(k) (Traditional)
- Applicant: Everyway Medical Instruments Co.,Ltd
- Decided: Nov 15, 2022 after 90 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Everyway Analog OTC TENS, model N601L 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/K222488
Methodology: https://510kreport.com/methodology