FDA.reportPublic FDA data

Comfortable Wheelchair Cushion

Primary DI
04713280202151
Brand
Comfortable Wheelchair Cushion
Company
SUN-SHINE LAND INTERNATIONAL LTD.
Model
WA-2553
Device description
Wheelchair seat cushion
Published
2023-07-20
Public version status
New
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
04713280202151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04713280202151047132802021514713280202151

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair seat cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair typically by improving posture, providing back and/or side support, compensating for seat height, relieving stress points, and providing pressure alleviation for the buttocks, lumbar region, and the legs, and/or by providing an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657954512
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04713280200188Tablet SplitterHA-41302023-07-20
04713280200201Tablet CrusherHA-41322023-07-20
047132802013143 in 1 Pill Splitter-BlackHA-4129-BK2023-07-20
047132802013213 in 1 Pill Splitter-BlueHA-4129-BL2023-07-20
047132802013383 in 1 Pill Splitter-PinkHA-4129-PK2023-07-20
047132802013523 in 1 Pill Splitter-WhiteHA-4129-WH2023-07-20
04713280201369Tablet SplitterHA-41282023-07-20
04713280208009Mini MassagerEA-81102023-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196312276MEDLINEMEDLINE INDUSTRIES, INC.IMP2026-02-04
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