Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031075901

FEI Number

3031075901

Entity Name

528 INNOVATIONS LLC

City/State/Country

Cedar Park, TX, US

Establishment Address

1405 Arrow Point Dr., Suite 1101, Cedar Park, TX 78613, US

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

528 Innovations LLC (Owner Number: 10090741)

Owner / Operator Contact Address

1320 Arrow Point Drive, Suite 303, Cedar Park, TX 78613, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

528i 5i Series

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2024-05-08

Official Correspondent

Kevin Johnson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

528 Innovations LLC

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 3031075901. Last updated year: 2026. Please use registration number 3031075901 when referencing this establishment in official correspondence.