WAVi Co.

Denver, CO, US

WAVI CO appears in FDA device records in Denver, CO. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 1 510(k) clearance for WAVi Co. in 2022.

Clearances by year, as a table

510(k) clearance decisions for WAVi Co., by decision year
Year	Clearances
2022	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K213900	WAVi SCAN EEG System and Accessories	GWQ	Substantially Equivalent	2022-05-06

Registered establishments

FDA registered establishments for WAVi Co., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3013757456	3013757456	WAVI CO	3957 N. Steele St., Denver, CO 80205 US	2026	GWQ GXY

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1942-2024	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).	Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.	Class II	2023-12-08	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain