Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013757456

FEI Number

3013757456

Entity Name

WAVI CO

City/State/Country

Denver, CO, US

Establishment Address

3957 N. Steele St., suite 1293, Denver, CO 80205, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

WAVi Co (Owner Number: 10055380)

Owner / Operator Contact Address

3857 steele st suite 1293, Denver, CO 80205, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213900

PMA Number

N/A

All Registered Proprietary Names

WAVi Headset and WAVi eSoc Single Use Electrode Contacts WAVi SCAN EEG System and Accessories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2017-07-17
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-10-27

Official Correspondent

David Oakley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

WAVi Co

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

Similar Registrations

Registration Number	Establishment Name	Location
3015614098	CGX, LLC	San Diego, CA, US
3015429360	SHAOXING YINGTUO HEALTHCARE CO.,LTD.	Shaoxing Zhejiang, CN
3004695199	INCEREB LTD	Dublin Dun Laoghaire-Rathdown, IE
3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013757456. Last updated year: 2026. Please use registration number 3013757456 when referencing this establishment in official correspondence.