FDA.reportPublic FDA data

Buddy Button - Blue

Primary DI
00186648000661
Brand
Buddy Button - Blue
Company
Ablenet, Inc.
Model
57600
Catalog number
57600
Published
2023-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KNOAccessories, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00186648000661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00186648000661001866480006611866480006610186648000661

GMDN Terms#

Term, Definition table
TermDefinition
Assistive electronic switchAn electronic device with a single operative feature designed to be used by a patient with a disability to activate or deactivate another device/product (e.g., toy, assistive speech generator). It is designed for use in the home and includes characteristics (size, conspicuousness, feel) to allow ease of use for a person with poor vision or other physical disability.

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
00850011150382Specs IC10000114100001142025-06-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00761887005402PryorPRYOR PRODUCTSKNO2026-05-31
04034089093246Abduction block (Hercules Prime, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089097640crotch pad with magnetic lock (Hercules Prime)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103334Back cushion, seat reducer (Swifty 3)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103341Seat minimizer Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103358Seat width reducer Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103365Lateral trunk supports, swing-away, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103372Lateral head supports, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103402Frame padding Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103419Canopy Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103433Rain poncho Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103464Pneumatic wheels, set, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103471under seat storage bag Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103488under seat storage basket Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103495Lateral trunk supports, rigid, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103501Drum brake, set, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103648Chin support rehabThomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089104010Incontinence Seat Cover size LThomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
00810178884643ViveVIVE HEALTH LLCKNO2026-03-06
00810178884766ViveVIVE HEALTH LLCKNO2026-03-06
00810178884773ViveVIVE HEALTH LLCKNO2026-03-06
00810178884780ViveVIVE HEALTH LLCKNO2026-03-06
00810178884575ViveVIVE HEALTH LLCKNO2025-12-05
00810178884889ViveVIVE HEALTH LLCKNO2025-12-05
00810178884896ViveVIVE HEALTH LLCKNO2025-12-05
00810178884902ViveVIVE HEALTH LLCKNO2025-12-05
00840363373645AxiomKI MOBILITY, LLCKNO2025-12-04
00840363373706AxiomKI MOBILITY, LLCKNO2025-12-04
00840363373874AxiomKI MOBILITY, LLCKNO2025-12-04
00840363374680AxiomKI MOBILITY, LLCKNO2025-12-04