FDA.reportPublic FDA data

Jay Lite Cushion

Primary DI
00016958054002
Brand
Jay Lite Cushion
Company
SUNRISE MEDICAL (US) LLC
Model
Jay Lite Cushion
Catalog number
E2603, E2607
Device description
The JAY Lite is an extremely lightweight foam wheelchair cushion that provides superior pressure distribution as well as heat and moisture dissipation.
Published
2021-05-12
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
00016958054002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00016958054002000169580540020169580540020016958054002

GMDN Terms#

Term, Definition table
TermDefinition
Foam-filled chair cushionA foam-filled pad designed to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. It may be used in a wheelchair and may contain weight-distribution air cells. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962525056
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
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
00016958056563Jay Fusion Jay Flow Fluid/Jay Air/ Jay Fluid w/CryoE2622/ E2623 / E2624 / E26252023-09-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196312276MEDLINEMEDLINE INDUSTRIES, INC.IMP2026-02-04
09420082696471Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696488Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696495Spex LimitedSPEX LIMITEDIMP2025-11-07
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09420082696518Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696525Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696532Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696549Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696556Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696563Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696570Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696587Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696594Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696600Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696617Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696624Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696631Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696648Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696655Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696662Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696679Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696686Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696693Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696709Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696716Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696723Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696730Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696747Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696754Spex LimitedSPEX LIMITEDIMP2025-11-07