Data / Medical devices / United States / Wavi Co
Wavi Co: FDA-registered device maker in Denver, CO, United States, 2 510(k) clearances
Wavi Co is registered with the FDA (registration 3013757456) in Denver, CO, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 6, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013757456
- Address
- 3957 N. Steele St. suite 1293, Denver, CO, United States, 80205
- Owner or operator
- WAVi Co (10055380)
- Roles
- Manufacturer
- First device listed
- July 17, 2017
- Registered through
- 2026
- Brand names listed
- WAVi Headset and WAVi eSoc Single Use Electrode Contacts, WAVi SCAN EEG System and Accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 6, 2022 | K213900 | WAVi SCAN EEG System and Accessories | GWQ | Substantially Equivalent | Wavi Co. | accessdata.fda.gov |
| April 28, 2017 | K162460 | WAVi Headset and WAVi eSoc Single Use Electrode Contacts | GXY | Substantially Equivalent | Wavi Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 8, 2023 | 94498 | Class II | Ongoing | 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 | Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study. | accessdata.fda.gov |
Compare with other makers
Updated May 31, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.