Specs IC 10000114

GUDID 00850011150382

With a 1 3/8-in/3.5-cm activation surface, the Specs switch is small enough to be worn, but is most often used as a mounted switch. The Specs switch includes a space saving flush base and a strap base for mounting around items. 24-inch strap included.

Ablenet, Inc.

Assistive speech generator
Primary Device ID00850011150382
NIH Device Record Keyf5b9de54-5ba5-4ebf-b736-17bde8969faa
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpecs IC
Version Model Number10000114
Catalog Number10000114
Company DUNS791664543
Company NameAblenet, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850011150382 [Primary]

FDA Product Code

ILQSystem, Communication, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-04
Device Publish Date2025-06-26

Devices Manufactured by Ablenet, Inc.

00850011150344 - BIG Candy Corn 22025-07-04 The BIG Candy Corn 2 accessibility switch uses highly sensitive proximity sensor technology for activation. Anytime the user is
00850011150382 - Specs IC2025-07-04With a 1 3/8-in/3.5-cm activation surface, the Specs switch is small enough to be worn, but is most often used as a mounted switch. The Specs switch includes a space saving flush base and a strap base for mounting around items. 24-inch strap included.
00850011150382 - Specs IC2025-07-04 With a 1 3/8-in/3.5-cm activation surface, the Specs switch is small enough to be worn, but is most often used as a mounted swit
00850011150399 - Buddy Button IC2025-07-04 The Buddy Button is a durable and reliable single switch that requires only the slightest touch of its 2.5-in/6.4-cm surface for
00850011150481 - QuickTalker Freestyle2025-06-26 The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to
00850011150467 - QuickTalker Freestyle Mini2025-06-25 The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to
00850011150443 - QuickTalker Freestyle Mini2025-05-23 The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to
00186648000609 - Blue2 4th Generation2023-07-03
00850011150276 - Blue2 FT2023-07-03

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.