# K253536: Evala Nerve Stimulator (EPNR002)

- Pathway: 510(k) (Traditional)
- Applicant: Epineuron Technologies, Inc.
- Decided: Feb 27, 2026 after 106 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K905045 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150005: Checkpoint, Checkpoint Head & Neck, Ndi Medical, LLC (2015)

## Indications for use
Evala is a single-use device intended to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability.

Source page: https://510kreport.com/device/K253536
Methodology: https://510kreport.com/methodology