WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rat…
WAVi Co. · Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
Open FDA's page for this record- Cfres ID
- 207320
- Product res number
- Z-1942-2024
- Event date initiated
- 2023-12-08
- Event date posted
- 2024-05-31
- Recall status
- Open, Classified
- Res event number
- 94498
- Product code
- GWQ
- Code info
- Desktop software version 1.0.0.2
- Firm FEI number
- 3013757456
- Recalling firm
- WAVi Co.
- Address 1
- 3857 N Steele St Ste 1293 3857 N Steele St
- Address 2
- Ste 1293
- City
- Denver
- State
- CO
- Postal code
- 80205-4996
- Additional info contact
- 303-761-4447
- 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.
- Root cause description
- No Marketing Application
- Product quantity
- 281
- Distribution pattern
- 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
- 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).
- Action
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
- Harmonized identifiers (openFDA)
- Device name
- Full-Montage Standard Electroencephalograph
- Medical specialty description
- Neurology
- Regulation number
- 882.1400
- Device class
- 2
- K number
- K991033, K791234, K171124, K110376, K100683, K220056, K964280, K910972, K925838, K820066, K905435, K113117, K260455, K822700, K992410, K191492, K770246, K103129, K904269, K150498, K791233, K971331, K171384, K863749, K863124, K143440, K010084, K923894, K791150, K000919, K001103, K860456, K914571, K894276, K983533, K122196, K820605, K883557, K854030, K870432 +149 more
- Registration number
- 8030229, 3008881376, 3023707151, 3008857629, 3013596024, 3011353843, 3013501110, 3010900508, 3003851073, 1531052, 1219324, 3012494290, 9681377, 3001687738, 3001570235, 3032109181, 3013757456, 3010611950, 3016852448, 3018094310, 3009649442, 3005733633, 1530224, 3013679558, 9710486, 3038189172, 3006125362, 3004753785, 3008729547, 3016701404, 3038896098, 1063925, 3004883754, 3011047165, 3008132398, 2184161, 3029984080, 9615126, 3007048291, 3016674095 +60 more
- FEI number
- 3008881376, 3023707151, 3008857629, 3013596024, 3011353843, 3013501110, 3002809369, 6736, 3010900508, 3003851073, 1219324, 3012494290, 1000139867, 3002806783, 3001687738, 3001570235, 3032109181, 3013757456, 3001139253, 3001610756, 3001452666, 3010611950, 3016852448, 3018094310, 3009649442, 3005733633, 3013679558, 3038189172, 3002716534, 3006125362, 3002459124, 3004753785, 3008729547, 3016701404, 3000206198, 3038896098, 3002757680, 3004883754, 3011047165, 3003208775 +60 more