FDA.reportPublic FDA data

O2 ACTIVE 9 14x17x3.5"

Primary DI
08717261055800
Brand
O2 ACTIVE 9 14x17x3.5"
Company
Vicair B.V.
Model
OCT9/3543
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
Rx
false
OTC
false
Sterile
false
Single use
false

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
08717261055800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717261055800087172610558008717261055800

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
Depth17Inch
Device Size Text, specify0
Width14Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
416605657
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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40080196312277MEDLINEMEDLINE INDUSTRIES, INC.IMP2026-02-04
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08717261074016Vicair 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
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00840117321915DMECare Solutions Ever-Soft Lumbar Support Cushion,18"Dynarex CorporationIMP2025-08-22
00840117321939DMECare Solutions Ever-Soft Lumbar Support Cushion, 20" Dynarex CorporationIMP2025-08-22
00840117321953DMECare Solutions Ever-Soft Lumbar Support Cushion, 22"Dynarex CorporationIMP2025-08-22
09420082600096Spex LimitedSPEX LIMITEDIMP2025-05-31
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09420082600065Spex LimitedSPEX LIMITEDIMP2025-05-30
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