FDA.reportPublic FDA data

Wavon

Primary DI
00860010877487
Brand
Wavon
Company
Ease Seating Systems
Model
Wavon 18x18
Device description
Alternating Pressure Seat Cushion
Published
2025-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010877487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010877487008600108774878600108774870860010877487

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
Length18Inch
Width18Inch

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
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

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