FDA.reportPublic FDA data

Assembly Required Distributors

Primary DI
00854362008125
Brand
Assembly Required Distributors
Company
Assembly Required Distributors Inc
Model
UP0510X-01-22
Catalog number
38126S27MR
Device description
"2"" Solid seat cushion, w/drop hooks for 26"" width chair, burgandy vinyl"
Published
2018-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

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
00854362008125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854362008125008543620081258543620081250854362008125

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair. It may be used to improve posture, provide back and/or side support, compensate for seat height, relieve stress points, and provide pressure alleviation for the buttocks, lumbar region, and the legs, and/or to provide 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
170562396
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860004575672Assembly Required Distributors IncWAM3000-012025-04-01
00860004575658Assembly Required Distributors Inc.AC1507-012023-07-06
00860004575665Assembly Required DistributorsWAM2000-012025-02-15
00854362008798Assembly Required DistributorsFSM1729-012024-10-03
00854362008637Assembly Required DistributorsCHM8905-012018-08-27
00854362008644Assembly Required DistributorsCHM8917-012018-08-27
00854362008651Assembly Required DistributorsCHM8903-012018-08-27
00854362008668Assembly Required DistributorsCHM8904-012018-08-27
00854362008675Assembly Required DistributorsCHM8906-012018-08-27
00854362008682Assembly Required DistributorsCHM8919-502018-08-27
00854362008699Assembly Required DistributorsCHM8907-012018-08-27
00854362008705Assembly Required DistributorsCHM8927-012018-08-28
00854362008712Assembly Required DistributorsCHM8086-012018-08-28
00854362008729Assembly Required DistributorsCHM8087-012018-10-03
00854362008736Assembly Required DistributorsCHM8911-012018-10-03
00854362008743Assembly Required DistributorsCHM8909-012018-10-03
00854362008750Assembly Required DistributorsCHM8923-012018-10-03
00854362008767Assembly Required DistributorsCHM8058-012018-10-03
00854362008774Assembly Required DistributorsCHM8907-012018-10-03
00854362008446Assembly Required DistributorsFSM1724-012018-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196312276MEDLINEMEDLINE INDUSTRIES, INC.IMP2026-02-04
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09420082696730Spex LimitedSPEX LIMITEDIMP2025-11-07
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09420082696754Spex LimitedSPEX LIMITEDIMP2025-11-07