FDA.reportPublic FDA data

AXIOM P

Primary DI
00850013379194
Brand
AXIOM P
Company
KI MOBILITY, LLC
Model
P
Device description
AXIOM CUSHION P
Published
2020-09-21
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840363302386PrimaryGS10
00840363302416PrimaryGS10
00840363302447PrimaryGS10
00840363302461PrimaryGS10
00840363302515PrimaryGS10
00840363302522PrimaryGS10
00840363302539PrimaryGS10
00840363302638PrimaryGS10
00840363302645PrimaryGS10
00840363302669PrimaryGS10
00840363302683PrimaryGS10
00840363302690PrimaryGS10
00840363302782PrimaryGS10
00840363302799PrimaryGS10
00840363302812PrimaryGS10
00840363302829PrimaryGS10
00840363302836PrimaryGS10
00850013379194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840363302386008403633023868403633023860840363302386
00840363302416008403633024168403633024160840363302416
00840363302447008403633024478403633024470840363302447
00840363302461008403633024618403633024610840363302461
00840363302515008403633025158403633025150840363302515
00840363302522008403633025228403633025220840363302522
00840363302539008403633025398403633025390840363302539
00840363302638008403633026388403633026380840363302638
00840363302645008403633026458403633026450840363302645
00840363302669008403633026698403633026690840363302669
00840363302683008403633026838403633026830840363302683
00840363302690008403633026908403633026900840363302690
00840363302782008403633027828403633027820840363302782
00840363302799008403633027998403633027990840363302799
00840363302812008403633028128403633028120840363302812
00840363302829008403633028298403633028290840363302829
00840363302836008403633028368403633028360840363302836
00850013379194008500133791948500133791940850013379194

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair. It may be used to improve posture, provide back and/or side support, compensate for seat height, relieve stress points, and provide pressure alleviation for the buttocks, lumbar region, and the legs, and/or to provide 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-981-1540sales@kimobility.com
+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
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09420082696730Spex LimitedSPEX LIMITEDIMP2025-11-07
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