FDA.reportPublic FDA data

Ease Cushion

Primary DI
00860010877470
Brand
Ease Cushion
Company
Ease Seating Systems
Model
Gen 2 22x22
Catalog number
10542
Device description
Alternating Pressure Wheelchair Cushion
Published
2025-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00860010877470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010877470008600108774708600108774700860010877470

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length22Inch
Width22Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080264585
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010877401Ease CushionGen 1 20x202024-05-15
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
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
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09420082696563Spex LimitedSPEX LIMITEDIMP2025-11-07
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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
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09420082696662Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696679Spex LimitedSPEX LIMITEDIMP2025-11-07
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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