FDA.report

Axiom

Primary DI
00840363365152
Brand
Axiom
Company
KI MOBILITY, LLC
Model
PXSP
Catalog number
PXSP1516BLK
Device description
Pediatric Axiom Skin Protection And Positioning Cushion 15 X 16, Black
Published
2024-01-02
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

Related Records

Product Codes

CodeName
IMPCUSHION, WHEELCHAIR

Product Code Classifications

CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840363365152PrimaryGS10

GMDN Terms

TermDefinition
Wheelchair seat cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair typically by improving posture, providing back and/or side support, compensating for seat height, relieving stress points, and providing pressure alleviation for the buttocks, lumbar region, and the legs, and/or by providing 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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
false
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 DIBrandModelCatalogPublished
00840363365404AxiomPXPLPXPL10102024-01-08
00840363365411AxiomPXPLPXPL10122024-01-08
00840363365428AxiomPXPLPXPL10142024-01-08
00840363365435AxiomPXPLPXPL12122024-01-08
00840363365442AxiomPXPLPXPL12142024-01-08
00840363365459AxiomPXPLPXPL12162024-01-08
00840363365466AxiomPXPLPXPL14122024-01-08
00840363365473AxiomPXPLPXPL14142024-01-08
00840363365480AxiomPXPLPXPL14162024-01-08
00840363365497AxiomPXPLPXPL16142024-01-08
00840363365503AxiomPXPLPXPL16162024-01-08
00840363365510AxiomPXPLPXPL16182024-01-08
00840363365527AxiomPXALPXAL10102024-01-08
00840363365534AxiomPXALPXAL10122024-01-08
00840363365541AxiomPXALPXAL10142024-01-08
00840363365558AxiomPXALPXAL12122024-01-08
00840363365565AxiomPXALPXAL12142024-01-08
00840363365572AxiomPXALPXAL12162024-01-08
00840363365589AxiomPXALPXAL14122024-01-08
00840363365596AxiomPXALPXAL14142024-01-08

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