Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004046843

FEI Number

3004046843

Entity Name

VIVOSONIC INC.

City/State/Country

TORONTO Ontario, CA

Establishment Address

222-5535 EGLINTON AVENUE WEST, TORONTO Ontario M9C 5K5, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Vivosonic Inc (Owner Number: 9043486)

Owner / Operator Contact Address

222-5535 EGLINTON AVENUE WEST, --, Toronto, CA-ON M9C 5K5, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K043396

PMA Number

N/A

All Registered Proprietary Names

Integrity V500 Integrity V500 Integrity

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2025-01-03
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2025-01-03
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2007-11-02
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2007-11-02

Official Correspondent

Trevor Rocheleau

US Agent Details

Katie Doane Business: Tobias Systems Email: usagent@fdabasics.com Phone: (716) 2208726

Related Public Records

Same Entity

Vivosonic Inc

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
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23

Similar Registrations

Registration Number	Establishment Name	Location
2011951	AMBCO ELECTRONICS, A CALIFORNIA CORP.	TUSTIN, CA, US
3013333417	HEAR.COM LLC (TELE-DX)	Coral Gables, FL, US
3013598036	WAHTS Hearing LLC	West Lebanon, NH, US
2113281	DIAGNOSTIC GROUP LLC	EDEN PRAIRIE, MN, US
3043496923	EARGYM LTD	London London, City of, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004046843. Last updated year: 2026. Please use registration number 3004046843 when referencing this establishment in official correspondence.