FDA.reportPublic FDA data

Ease Cushion

Primary DI
00860000915335
Brand
Ease Cushion
Company
Ease Seating Systems
Model
16x18 Cushion
Device description
"16"" x 18"" cushion "
Published
2020-02-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000915335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000915335008600009153358600009153350860000915335

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080264585
Device count
1
Premarket exempt
true
Serial number
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
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
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

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Primary DI, Brand, Company table
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04719876192219TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
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04719893356922WellellWellell Inc.FNM2026-03-20
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