FDA.reportPublic FDA data

Specs IC

Primary DI
00850011150382
Brand
Specs IC
Company
Ablenet, Inc.
Model
10000114
Catalog number
10000114
Device description
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.
Published
2025-06-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILQSystem, Communication, Powered
KNOAccessories, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILQSystem, Communication, PoweredPhysical Medicine2
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011150382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011150382008500111503828500111503820850011150382

GMDN Terms#

Term, Definition table
TermDefinition
Assistive speech generatorAn electrically-powered device designed to facilitate communication by a patient with a disability and/or cognitive impairment by providing buttons with images that when pressed produce audible pre-recorded words or phrases associated with the images. It is a unit with a set of buttons/keyboard displaying symbols/pictures, a recording function, and a speaker. It is intended for use both in the home and healthcare facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791664543
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00186648000708Big Beamer Transmitter10034300100343002023-06-22
00186648000548SuperTalker FeatherTouch10000031100000312023-06-21
00850011150344BIG Candy Corn 210000077100000772025-06-26
00850011150061BIGmack10000041100000412023-06-21
00850011150399Buddy Button IC10000115100001152025-06-26
00850011150481QuickTalker Freestyle10000129100001292025-06-18
00850011150467QuickTalker Freestyle Mini10000127100001272025-06-17
00850011150443QuickTalker Freestyle Mini10000125100001252025-05-15
00186648000609Blue2 4th Generation10000033100000332023-06-23
00850011150276Blue2 FT10000053100000532023-06-23
00850011150283QuickTalker Freestyle70000117700001172023-06-23
00850011150290QuickTalker Freestyle Mini70000119700001192023-06-23
00186648000180Pillow Switch58750587502023-06-22
00186648000203Jelly Bean 10033400100334002023-06-22
00186648000210Specs Switch - Red100SPR100SPR2023-06-22
00186648000227Big Red Switch10033500100335002023-06-22
00186648000296Specs Switch - Black100SPBK100SPBK2023-06-22
00186648000302Specs Switch - Blue100SPBL100SPBL2023-06-22
00186648000319Specs Switch - Green100SPG100SPG2023-06-22
00186648000326Specs Switch - Yellow100SPY100SPY2023-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828196468RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-05-27
00810178884575ViveVIVE HEALTH LLCKNO2025-12-05
00810178884889ViveVIVE HEALTH LLCKNO2025-12-05
00810178884896ViveVIVE HEALTH LLCKNO2025-12-05
00810178884902ViveVIVE HEALTH LLCKNO2025-12-05
09420051798632Spex LimitedSPEX LIMITEDKNO2025-10-01
09420051798649Spex LimitedSPEX LIMITEDKNO2025-10-01
G783OSKOL20IrisbondIRISBOND CROWDBONDING SL.ILQ2025-08-01
00810178883516ViveVIVE HEALTH LLCKNO2025-07-17
00810113579887ViveVIVE HEALTH LLCKNO2025-05-20
00810178880676ViveVIVE HEALTH LLCKNO2025-05-20
00810178880683ViveVIVE HEALTH LLCKNO2025-05-20
00810178880690ViveVIVE HEALTH LLCKNO2025-05-20
00810178882656ViveVIVE HEALTH LLCKNO2025-05-19
00810178882861ViveVIVE HEALTH LLCKNO2025-05-19
00810113578699ViveVIVE HEALTH LLCKNO2024-09-13
00810113576817ViveVIVE HEALTH LLCKNO2024-07-17
00810113576824ViveVIVE HEALTH LLCKNO2024-07-17
00810113576831ViveVIVE HEALTH LLCKNO2024-07-17
00810113574738ViveVIVE HEALTH LLCKNO2024-01-12
00810113574745ViveVIVE HEALTH LLCKNO2024-01-12
00810113575308ViveVIVE HEALTH LLCKNO2024-01-12
00810113575315ViveVIVE HEALTH LLCKNO2024-01-12
00810113575360ViveVIVE HEALTH LLCKNO2024-01-12
00812324010319Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010326Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010333Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010340Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010357Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010364Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13