Facility

WAVI CO

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

4inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3013757456
Establishment type	Manufacture Medical Device
Location	3957 N. Steele St. Denver, CO, US 80205
Registration status	Active · expires 2026
Parent company	WAVi Co (owner-operator 10055380)
Brand names	WAVi SCAN EEG System and Accessories

Activity by year

Recalls (1)
Inspections (4)
Warning letters (1)

Devices registered here (1)

Full-Montage Standard Electroencephalograph
Product code GWQ (opens in a new tab) · Class II · Neurology · 21 CFR 882.1400

Recalls & enforcement

Class IIOngoing2023-12-08
Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.

FDA inspections (4)

NAI2023-03-29
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2022-03-31
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2018-12-21
Voluntary Action Indicated · Compliance: Devices · citations posted
NAI2018-01-29
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2023-10-20
Warning Letter (opens in a new tab) · Denver Colorado

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by WAVi Co

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “WAVI CO (FEI 3013757456) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013757456-wavi-co/

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