Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030411493

FEI Number

3030411493

Entity Name

IOTAMOTION, INC.

City/State/Country

Vadnais Heights, MN, US

Establishment Address

4205 White Bear Pkwy Ste 600, Vadnais Heights, MN 55110, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

iotaMotion, Inc. (Owner Number: 10083773)

Owner / Operator Contact Address

4205 White Bear Parkway, STE 600, Saint Paul, MN 55110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN190055

PMA Number

N/A

All Registered Proprietary Names

iotaSOFT Insertion System - Drive Unit, Controller and Accessories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QQH	Powered Insertion System For A Cochlear Implant Electrode Array	Ear, Nose, Throat	Class 2	874.4450	2021-12-17

Official Correspondent

Khamporn Pendergrass

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

iotaMotion, 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 3030411493. Last updated year: 2026. Please use registration number 3030411493 when referencing this establishment in official correspondence.