BEUDAMED
    FDA Enforcement Class II Ongoing

    WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporates use of the firm's cleared EEG analysis technology (the WAVi SCAN EEG System and Accessories, and the WAVi Headset and eSoc Single Use Electrode Contacts).

    Recall: Z-1942-2024 · Reported June 12, 2024

    Enforcement

    Recall Number
    Z-1942-2024
    Event ID
    94498
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    WAVi Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2024
    Initiation Date
    December 8, 2023
    Classification Date
    May 31, 2024
    Address
    3857 N Steele St Ste 1293, N/A, Denver, CO, 80205-4996, United States

    Description

    WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporates use of the firm's cleared EEG analysis technology (the WAVi SCAN EEG System and Accessories, and the WAVi Headset and eSoc Single Use Electrode Contacts).

    Reason

    Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.

    Code Info

    Desktop software version 1.0.0.2

    Distribution

    US: NC, TX, IL, NV, AZ, NY, CA, MI, KS, AL, FL, MD, UT, WA, PA, GA, AR, NM, CO, IA, CT, IN, VA, LA, HI, MA, OH, OR, MO, KY, ID

    Quantity

    281