ABLENET, INC.

FDA Device Registration & Listing · Roseville, MN, US · Registration 3001576173

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
3001576173
FEI Number
3001576173
Entity Name
ABLENET, INC.
City/State/Country
Roseville, MN, US
Establishment Address
2625 PATTON RD, Roseville, MN 55113, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AbleNet (Owner Number: 10046361)
Owner / Operator Contact Address
2625 Patton Road, Roseville, MN 55113, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

BIG Candy Corn Micro Light Buddy Button - Black Buddy Button - Green Specs - Green Buddy Button - Yellow Big Beamer Big Red Switch Mini Cup Switch BIG Candy Corn Switch Specs - Yellow Big Buddy Button - Red Jelly Bean Buddy Button - Blue Original Receiver LITTLE Candy Corn Switch Specs - Black Buddy Button - Red Specs - Blue Pillow Switch Jelly Beamer Specs - Red Blue2 Bluetooth Switch QuickTalker FreeStyle Pro QuickTalker FreeStyle Mini QuickTalker FreeStyle Quicktalker FT 12 TalkingBrix 2 QuickTalker FreeStyle Touch iTalk2 BIG Step-by-Step Quicktalker FT 23 LITTLEmack BIGmack LITTLE Step-by-Step iTalk4 with Levels Quicktalker FT 7 SuperTalker FT BIG Talkingbrix Choice

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KNO Accessories, Wheelchair Physical Medicine Class 1 890.3910 2021-06-02
ILQ System, Communication, Powered Physical Medicine Class 2 890.3710 2014-03-12

Official Correspondent

Jennifer Thalhuber

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AbleNet
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2016 Lifeline Systems, Incorporated 2
Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001576173. Last updated year: 2026. Please use registration number 3001576173 when referencing this establishment in official correspondence.
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