FDA.reportPublic FDA data

Axiom Back

Primary DI
00850013379170
Brand
Axiom Back
Company
KI MOBILITY, LLC
Model
AXDL
Device description
AXIOM DEEP LATERAL BACKREST
Published
2020-09-21
Public version status
Update
Distribution status
Not 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
00850013379170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013379170008500133791708500133791700850013379170

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
00850013379279AXIOMAS2023-05-08
00850013379286AXIOMASP2023-05-08
00850013379149AXIOM GG2020-09-21
00850013379156AXIOM SPVSPV2020-09-21
00850013379163Axiom BackAXLB2020-09-21
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
00840363372396AxiomAxiom PXPPXP1111BLKIC2025-12-05
00840363372402AxiomAxiom PXPPXP1112BLKIC2025-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540147003036MANUAL RECLINE ASSEMBLY WITH CROSSBRACEMotion Concepts IncKNN2026-07-06
07540147003043MANUAL RECLINE ASSEMBLY WITH CROSSBRACEMotion Concepts IncKNN2026-07-06
07540147003050Matrx MAC back Interface, Recline System UL MAXX & Adult StanderMotion Concepts IncKNN2026-07-03
07540147003067Matrx MAC back Interface, Tilt Only, UL & MINI MAXXMotion Concepts IncKNN2026-07-03
06972077026266EmeraldXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026273EmeraldXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026327EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026334EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026341EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
09420082689060Spex SeatingSPEX LIMITEDKNN2026-04-30
09420082689077Spex SeatingSPEX LIMITEDKNN2026-04-30
09420082695511Spex SeatingSPEX LIMITEDKNN2026-04-30
06934726614484Battery ChargerLongfian Scitech Co., Ltd.KNN2026-04-25
10080196470723MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-16
10884389115954MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-16
40884389115788MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-13
09420082699441Spex SeatingSPEX LIMITEDKNN2026-04-04
09420082699458Spex SeatingSPEX LIMITEDKNN2026-04-04
09420051799851Spex SeatingSPEX LIMITEDKNN2025-11-21
05407008321222mo-vismo-VisKNN2025-11-19
05407008321239mo-vismo-VisKNN2025-11-19
09420051706521Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051725195Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051747517Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051747746Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051747852Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051747869Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051770560Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051770584Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051770676Spex LimitedSPEX LIMITEDKNN2025-11-07