Recall Z-1942-2024— WAVi Co.
Class II · Ongoing
Class II FDA medical device recall by WAVi Co., initiated 2023-12-08. FDA's recall record names no specific 510(k) clearance for this event. 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).. 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..
- Recalling firm
- WAVi Co.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-08
- Firm location
- Denver, CO, United States
Product 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 for recall
Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
Data sourced from openFDA. This site is unofficial and independent of the FDA.