WAVi Research EEG System (WAVi) – Research Study Closure (2023)
Research EEG system components being returned following FDA warning letter.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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).
Brand
WAVi Co.
Lot Codes / Batch Numbers
Desktop software version 1.0.0.2
Products Sold
Desktop software version 1.0.0.2
WAVi Co. is recalling WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruc due to Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
Recommended Action
Per FDA guidance
On 12/8/23, notices were emailed to customers informing them that the research study was being closed so the affected systems should be returned. The study sponsor would contact customers to help facilitate return. Customers with questions could reply to the email sent from wavi@wavimed.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MO, NV, NM, NY, NC, OH, OR, PA, TX, UT, VA, WA
Page updated: Jan 10, 2026