FDA.reportPublic FDA data

Axiom

Primary DI
00850013379248
Brand
Axiom
Company
KI MOBILITY, LLC
Model
ACS
Device description
AXIOM CUSTOM SEATING DEFINED AS SEAT, BACK OR COMBINATION OF BOTH
Published
2020-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00850013379248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013379248008500133792488500133792480850013379248

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.

Contacts#

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

Regulatory Flags#

DUNS number
609305656
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420082931091Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931107Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931114Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931121Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931138Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931145Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931152Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931169Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931176Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931183Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931190Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931206Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931213Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931220Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931237Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931244Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931251Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931268Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931275Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931282Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931299Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931305Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931312Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931329Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931336Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931343Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931350Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931367Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931374Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931381Spex LimitedSPEX LIMITEDKNN2026-07-31