FDA.reportPublic FDA data

Ease Cushion

Primary DI
00860010877401
Brand
Ease Cushion
Company
Ease Seating Systems
Model
Gen 1 20x20
Published
2024-05-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00860010877401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010877401008600108774018600108774010860010877401

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure chair cushion, reusableA pad intended to be placed on the seat of a chair and designed with parallel chambers that are alternately filled with forced-air to actively change an occupant's buttocks-chair contact points, 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. This is a reusable device.

Regulatory Flags#

DUNS number
080264585
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010877418Ease CushionGen 1 18x182024-05-15
00860010877425Ease CushionGen 1 16x162024-05-15
00860010877432Ease CushionGen 1 22x222024-05-15
00860010877487WavonWavon 18x182025-09-08
00860010877449Ease CushionGen 2 16x16105122025-09-05
00860010877456Ease CushionGen 2 18x18105222025-09-05
00860010877463Ease CushionGen 2 20x20105322025-09-05
00860010877470Ease CushionGen 2 22x22105422025-09-05
00860002071237Ease CushionLite 2020-11-09
00860002071220Ease CushionStandard Pump2020-07-28
00860000915304Ease Cushion Pump 2020-02-04
00860000915311Ease Cushion Patient Matched Cushion 2020-02-04
00860000915328Ease Cushion 16x16 Cushion2020-02-04
00860000915335Ease Cushion16x18 Cushion2020-02-04
00860000915342Ease Cushion16x20 Cushion 2020-02-04
00860000915359Ease Cushion18x16 Cushion2020-02-04
00860000915366Ease Cushion18x18 Cushion2020-02-04
00860000915373Ease Cushion18x20 Cushion2020-02-04
00860000915380Ease Cushion 20x16 Cushion 2020-02-04
00860000915397Ease Cushion 20x18 Cushion2020-02-04

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
09420082696501Spex LimitedSPEX LIMITEDIMP2025-11-07
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