Jay Fusion

Primary DI
00016958056563
Brand
Jay Fusion
Company
SUNRISE MEDICAL (US) LLC
Model
Jay Flow Fluid/Jay Air/ Jay Fluid w/Cryo
Catalog number
E2622/ E2623 / E2624 / E2625
Device description
The JAY Fusion® is an adjustable wheelchair cushion engineered to protect against pressure injuries that features the choice of JAY Flow® Fluid, JAY® Air™, or JAY Fluid with Cryo™ Technology insert options for optimal comfort and support.
Published
2023-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IMPCushion, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00016958056563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00016958056563000169580565630169580565630016958056563

GMDN Terms#

Term, Definition table
TermDefinition
Air-filled chair cushion, dynamicAn electrically-powered, air-inflated arrangement of cushions and supports intended to be attached to a chair (e.g., wheelchair, dining chair) to provide comfort, improve posture, and help prevent pressure sores for the occupant, who is typically a patient affected by neuromuscular dysfunction. The device is composed of different cushions (e.g., lumbar, pelvic) which are independently inflated/deflated by an attendant and/or the occupant via electronic controls; the device may feature automatic inflation/deflation with occupant movement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962525056
Device count
1
Premarket exempt
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00016958061888JAY LITEPRO CUSHIONJLPXXYY2026-03-05
00016958057591RGKOctane2023-09-05
00016958059373RGK Octane Sub4Sub 42023-09-05
00016958060249RGK Octane FXFX2023-09-05
00016958053593Quickie QX/QXiQX/QXiEIF62021-05-04
00016958053661Quickie SR45SR45EIZ92021-05-04
00016958056761Quickie XtenderQuickie XtenderEIXT2021-05-03
00016958058413Cool Cube / TouchDrive 2CCB / TD2SWI2021-05-12
00016958058437CTRL+5, Dual Pro, Joystick in a Can, MicroGuide, MicroPilot, and Tough JoyStickSwitch-ItSWI2021-05-12
00016958050110Jay EasyEasyE2607 / E26082023-09-12
00016958050127Jay Basic BackBasic Back2023-09-12
00016958050134Jay Focus Point BackFocus Point Back2023-09-12
00016958053135Jay Encompass BackEncompass2023-09-12
00016958053647Zippie VoyageVoyage; Voyage VIPEIZ14. EIZ16, EIZ182023-09-12
00016958058451Switch-It MicroGuide, MicroPilot, VersaGuide, VersaGuideEZ, SWI2023-09-12
00016958059694 Xtreme X8 4WDXtreme X8EIMM2023-09-12
00016958059380EmpluseF35EISP112025-04-21
00016958059526QuickieQS5 XEIF72024-12-02
00016958059366EmpluseR20EISP92024-07-24
00016958059465Empulse R90EISP82024-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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