FDA.reportPublic FDA data

Axiom

Primary DI
00840363374796
Brand
Axiom
Company
KI MOBILITY, LLC
Model
Axiom PXSP
Catalog number
PXSP1415BLUIC
Device description
PEDIATRIC AXIOM SKIN PROTECTION AND POSITIONING INCONTINENT CUSHION, 1415, BLU
Published
2025-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMPCushion, Wheelchair
KNOACCESSORIES, WHEELCHAIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840363374796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840363374796008403633747968403633747960840363374796

GMDN Terms#

Term, Definition table
TermDefinition
Medical cushion coverA device intended to cover a medical cushion (e.g., birthing cushion, lumbar cushion, wheelchair cushion) during use to protect the cushion from dirt/debris to maintain hygiene. It may be dedicated to a specific type of cushion or non-dedicated; it is not intended for surgical use and is not intended to cover a pillow primarily used in bed. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)981-1540sales@kimobility.com

Regulatory Flags#

DUNS number
609305656
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840363369624AxiomAxiom GXG1719IC2025-12-02
00840363372259AxiomAxiom PXPPXP0809BLKIC2025-12-05
00840363372280AxiomAxiom PXPPXP0909BLKIC2025-12-05
00840363372303AxiomAxiom PXPPXP1008BLKIC2025-12-05
00840363372327AxiomAxiom PXPPXP1010BLKIC2025-12-05
00840363372358AxiomAxiom PXPPXP1013BLKIC2025-12-05
00840363372365AxiomAxiom PXPPXP1014BLKIC2025-12-05
00840363372389AxiomAxiom PXPPXP1110BLKIC2025-12-05
00840363372396AxiomAxiom PXPPXP1111BLKIC2025-12-05
00840363372402AxiomAxiom PXPPXP1112BLKIC2025-12-05
00840363372419AxiomAxiom PXPPXP1113BLKIC2025-12-05
00840363372440AxiomAxiom PXPPXP1211BLKIC2025-12-05
00840363372464AxiomAxiom PXPPXP1213BLKIC2025-12-05
00840363372471AxiomAxiom PXPPXP1214BLKIC2025-12-05
00840363372501AxiomAxiom PXPPXP1310BLKIC2025-12-05
00840363372518AxiomAxiom PXPPXP1311BLKIC2025-12-05
00840363372525AxiomAxiom PXPPXP1312BLKIC2025-12-05
00840363372532AxiomAxiom PXPPXP1313BLKIC2025-12-05
00840363372549AxiomAxiom PXPPXP1314BLKIC2025-12-05
00840363372563AxiomAxiom PXPPXP1316BLKIC2025-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00761887005402PryorPRYOR PRODUCTSKNO2026-05-31
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04034089097640crotch pad with magnetic lock (Hercules Prime)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103334Back cushion, seat reducer (Swifty 3)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103341Seat minimizer Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103358Seat width reducer Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103365Lateral trunk supports, swing-away, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103372Lateral head supports, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103402Frame padding Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103419Canopy Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103433Rain poncho Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103464Pneumatic wheels, set, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103471under seat storage bag Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103488under seat storage basket Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103495Lateral trunk supports, rigid, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103501Drum brake, set, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103648Chin support rehabThomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089104010Incontinence Seat Cover size LThomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
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