FDA.reportPublic FDA data

Axiom

Primary DI
00804363370172
Brand
Axiom
Company
KI MOBILITY, LLC
Model
Axiom S
Catalog number
XS1819IC
Device description
Axiom S - Skin Protection Cushion with Incontinent Cover 18 X 19
Published
2025-12-02
Public version status
New
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
KNOACCESSORIES, WHEELCHAIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00804363370172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00804363370172008043633701728043633701720804363370172

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
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
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
00810226442245ViveVIVE HEALTH LLCKNO2026-08-21
00810226442290ViveVIVE HEALTH LLCKNO2026-08-21
00810226441965ViveVIVE HEALTH LLCKNO2026-08-14
00810226441972ViveVIVE HEALTH LLCKNO2026-08-14
00810226441385ViveVIVE HEALTH LLCKNO2026-07-28
00860014392757ICON Oxygen Tank HolderCarrier Medical LLCKNO2026-07-13
00860014392764PerfectFit Oxygen Tank HolderCarrier Medical LLCKNO2026-07-13
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
00810178884643ViveVIVE HEALTH LLCKNO2026-03-06
00810178884766ViveVIVE HEALTH LLCKNO2026-03-06
00810178884773ViveVIVE HEALTH LLCKNO2026-03-06