Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010550507

FEI Number

3010550507

Entity Name

SPEECHVIVE INC.

City/State/Country

Lafayette, IN, US

Establishment Address

603 Wexford Dr, Lafayette, IN 47905, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SpeechVive Inc. (Owner Number: 10045390)

Owner / Operator Contact Address

603 Wexford Drive, Lafayette, IN 47905, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SpeechVive

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KTH	Device, Anti-Stammering	Ear, Nose, Throat	Class 1	874.5840	2013-11-11

Official Correspondent

Steve Mogensen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SpeechVive Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010550507. Last updated year: 2026. Please use registration number 3010550507 when referencing this establishment in official correspondence.