LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253536

    Validate with FDA (Live)

    Device Name
    Evala Nerve Stimulator (EPNR002)
    Manufacturer
    Epineuron Technologies, Inc.
    Date Cleared
    2026-02-27

    (106 days)

    Product Code
    ETN
    Regulation Number
    874.1820
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Age Range
    All
    Reference & Predicate Devices
    K150005
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended 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.

    Device Description

    The Evala Nerve Stimulator is a small handheld device used by a surgeon to deliver electrical stimulation intraoperatively to test nerve integrity and muscle excitability. This is a sterile disposable device designed to be simple to use with one-handed control.

    The device employs a bipolar stimulating probe to deliver a charge-balanced, biphasic electrical stimulus to nerve tissue, allowing surgeons to monitor the resulting muscle responses. The device contains embedded firmware that controls the function of the stimulator. The firmware cannot be modified by the user. The stimulator is powered by an internal battery which is not user replaceable. The surgeon is notified of stimulation delivery and device status via the visual indicators at the front of the device and vibratory (haptic) feedback felt on the body of the device.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1