FDA.reportPublic FDA data

Axiom

Primary DI
00840363373645
Brand
Axiom
Company
KI MOBILITY, LLC
Model
Axiom PXP
Catalog number
PXP1316PURIC
Device description
PEDIATRIC AXIOM POSITIONING INCONTINENT CUSHION, 1316, PUR
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
00840363373645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840363373645008403633736458403633736450840363373645

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
00850013379200AXIOM SPFSPF2020-09-21
00850013379279AXIOMAS2023-05-08
00850013379286AXIOMASP2023-05-08
00850013379149AXIOM GG2020-09-21
00850013379156AXIOM SPVSPV2020-09-21
00850013379163Axiom BackAXLB2020-09-21
00850013379170Axiom BackAXDL2020-09-21
00850013379187AXIOM SS2020-09-21
00850013379194AXIOM PP2020-09-21
00850013379217Axiom BackAXPB2020-09-21
00850013379224Axiom BackAXPL2020-09-21
00850013379248AxiomACS2020-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014392757ICON Oxygen Tank HolderCarrier Medical LLCKNO2026-07-13
00860014392764PerfectFit Oxygen Tank HolderCarrier Medical LLCKNO2026-07-13
07540147004040Matrx MAC BackMotion Concepts IncIMP2026-07-03
07540147004057Matrx MAC-HUG BackMotion Concepts IncIMP2026-07-03
00761887005495CorCytePRYOR PRODUCTSKNO2026-06-22
00810178889952ViveVIVE HEALTH LLCKNO2026-06-10
00761887005402PryorPRYOR PRODUCTSKNO2026-05-31
04034089093246Abduction block (Hercules Prime, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
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
09420082696471Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696488Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696495Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696501Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696518Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696525Spex LimitedSPEX LIMITEDIMP2025-11-07