FDA.reportPublic FDA data

"ADJUSTER 12 O2 18x15x5"""

Primary DI
08717261065915
Brand
"ADJUSTER 12 O2 18x15x5"""
Company
Vicair B.V.
Model
OAD12/4538
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
08717261065915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717261065915087172610659158717261065915

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
Depth15Inch
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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