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WAVi Co.
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for WAVi Co. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-06-12FDA-DeviceClass IIWAVi 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).
Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
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