FDADecember 8, 2023device
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, a...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
wavi
Recall history
No related federal recalls on record for this brand yet.
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