FDA.reportPublic FDA data

"O2 ADJUSTER 10 18x16x4"""

Primary DI
08717261041209
Brand
"O2 ADJUSTER 10 18x16x4"""
Company
Vicair B.V.
Model
OAD10/4540
Device description
Wheelchair cushion
Published
2023-12-14
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
08717261041209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717261041209087172610412098717261041209

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth16Inch
Device Size Text, specify0
Width18Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
416605657
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717261074016"Vicair 4 ZV 18x18x3.25"""FZV/45452025-12-03
08717261040882O2 ADJUSTER 10 OAD10/SPECIAL SIZE2023-12-14
08717261040899"O2 ADJUSTER 10 14x14x4"""OAD10/35352023-12-14
08717261040905"O2 ADJUSTER 10 14x15x4"""OAD10/35382023-12-14
08717261040912"O2 ADJUSTER 10 14x16x4"""OAD10/35402023-12-14
08717261040929"O2 ADJUSTER 10 14x17x4"""OAD10/35432023-12-14
08717261040936"O2 ADJUSTER 10 14x18x4"""OAD10/35452023-12-14
08717261040943"O2 ADJUSTER 10 15x14x4"""OAD10/38352023-12-14
08717261040950"O2 ADJUSTER 10 15x15x4"""OAD10/38382023-12-14
08717261040967"O2 ADJUSTER 10 15x16x4"""OAD10/38402023-12-14
08717261040974"O2 ADJUSTER 10 15x17x4"""OAD10/38432023-12-14
08717261040981"O2 ADJUSTER 10 15x18x4"""OAD10/38452023-12-14
08717261040998"O2 ADJUSTER 10 15x19x4"""OAD10/38482023-12-14
08717261041001"O2 ADJUSTER 10 16x14x4"""OAD10/40352023-12-14
08717261041018"O2 ADJUSTER 10 16x15x4"""OAD10/40382023-12-14
08717261041025"O2 ADJUSTER 10 16x16x4"""OAD10/40402023-12-14
08717261041032"O2 ADJUSTER 10 16x17x4"""OAD10/40432023-12-14
08717261041049"O2 ADJUSTER 10 16x18x4"""OAD10/40452023-12-14
08717261041056"O2 ADJUSTER 10 16x19x4"""OAD10/40482023-12-14
08717261041063"O2 ADJUSTER 10 16x20x4"""OAD10/40502023-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00016958061888JAY LITEPRO CUSHIONSUNRISE MEDICAL (US) LLCIMP2026-03-05
H933EZ161896Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IMP2026-02-26
40080196312277MEDLINEMEDLINE INDUSTRIES, INC.IMP2026-02-04
09420051799745Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799752Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799769Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799776Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799783Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799790Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799820Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799837Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799844Spex SeatingSPEX LIMITEDIMP2025-12-12
09420051799738Spex LimitedSPEX LIMITEDIMP2025-12-05
09420051799806Spex LimitedSPEX LIMITEDIMP2025-12-05
09420051799813Spex LimitedSPEX LIMITEDIMP2025-12-05
08717261074016"Vicair 4 ZV 18x18x3.25"""Vicair B.V.IMP2025-12-03
00860014212307Matrix AIREZ Custom BackMatrix Seating USA, LLCIMP2025-11-19
00860014212314Matrix AIREZ Custom CushionMatrix Seating USA, LLCIMP2025-11-19
00860014212321Matrix Custom Seat CushionMatrix Seating USA, LLCIMP2025-11-19
00860010877449Ease CushionEase Seating SystemsIMP2025-09-05
00860010877456Ease CushionEase Seating SystemsIMP2025-09-05
00860010877463Ease CushionEase Seating SystemsIMP2025-09-05
00860010877470Ease CushionEase Seating SystemsIMP2025-09-05
00840117321915"DMECare Solutions Ever-Soft Lumbar Support Cushion,18"""Dynarex CorporationIMP2025-08-22
00840117321939"DMECare Solutions Ever-Soft Lumbar Support Cushion, 20"" "Dynarex CorporationIMP2025-08-22
00840117321953"DMECare Solutions Ever-Soft Lumbar Support Cushion, 22"""Dynarex CorporationIMP2025-08-22
09420082600096Spex LimitedSPEX LIMITEDIMP2025-05-31
09420082600133Spex LimitedSPEX LIMITEDIMP2025-05-31
09420082600065Spex LimitedSPEX LIMITEDIMP2025-05-30
09420082600072Spex LimitedSPEX LIMITEDIMP2025-05-30