FDA.reportPublic FDA data

Axiom Back

Primary DI
00850013379224
Brand
Axiom Back
Company
KI MOBILITY, LLC
Model
AXPL
Device description
AXIOM POSTERIOR LATERAL BACKREST
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
KNNComponents, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNNComponents, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840363300306PrimaryGS10
00840363300313PrimaryGS10
00840363300351PrimaryGS10
00840363300429PrimaryGS10
00840363300443PrimaryGS10
00840363300467PrimaryGS10
00840363300504PrimaryGS10
00840363300542PrimaryGS10
00840363300566PrimaryGS10
00840363300580PrimaryGS10
00840363300597PrimaryGS10
00840363300634PrimaryGS10
00840363300641PrimaryGS10
00840363300665PrimaryGS10
00840363300689PrimaryGS10
00840363300696PrimaryGS10
00850013379224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840363300306008403633003068403633003060840363300306
00840363300313008403633003138403633003130840363300313
00840363300351008403633003518403633003510840363300351
00840363300429008403633004298403633004290840363300429
00840363300443008403633004438403633004430840363300443
00840363300467008403633004678403633004670840363300467
00840363300504008403633005048403633005040840363300504
00840363300542008403633005428403633005420840363300542
00840363300566008403633005668403633005660840363300566
00840363300580008403633005808403633005800840363300580
00840363300597008403633005978403633005970840363300597
00840363300634008403633006348403633006340840363300634
00840363300641008403633006418403633006410840363300641
00840363300665008403633006658403633006650840363300665
00840363300689008403633006898403633006890840363300689
00840363300696008403633006968403633006960840363300696
00850013379224008500133792248500133792240850013379224

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair back restA padded support (typically vinyl covered) designed to attach to the back of a wheelchair. It typically replaces the wheelchair's sling upholstery and provides the wheelchair occupant with improved back support, posture, air circulation, and comfort.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length8Inch
Length10Inch
Length12Inch
Length16Inch
Length18Inch
Length20Inch
Length22Inch

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06972077026495EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026266EmeraldXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026273EmeraldXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026327EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
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06972077026341EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
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