AIOMEGA, LLC

FDA Device Registration & Listing · Tyler, TX, US · Registration 3030562551

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3030562551
FEI Number
3030562551
Entity Name
AIOMEGA, LLC
City/State/Country
Tyler, TX, US
Establishment Address
3187 Paluxy drive, Tyler, TX 75701, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AIOMEGA, LLC (Owner Number: 10090223)
Owner / Operator Contact Address
3187 Paluxy drive, Tyler, TX 75701, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

AIO BREATHE AIO BREATHE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LRK Device, Anti-Snoring Dental Class 2 872.5570 2025-11-18
LQZ Device, Jaw Repositioning Dental Class 2 872.5570 2025-11-18
LRK Device, Anti-Snoring Dental Class 2 872.5570 2024-02-29
LQZ Device, Jaw Repositioning Dental Class 2 872.5570 2024-02-29

Official Correspondent

Raghavendra Ghuge

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AIOMEGA, LLC
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
K122391 Medtronic Xomed, Inc. MEDTRONIC XOMED, INC. 2013-01-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030562551. Last updated year: 2026. Please use registration number 3030562551 when referencing this establishment in official correspondence.
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