FDA-Device2024-06-12Class II
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).
WAVi Co.
Hazard
Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
Sold states
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
Affected count
281
Manufactured in
3857 N Steele St Ste 1293, N/A, Denver, CO, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1942-2024Don't want to check this manually?
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