FDA.report

Axiom

Primary DI
00840363300481
Brand
Axiom
Company
KI MOBILITY, LLC
Model
PL
Catalog number
AXPL1620
Device description
Posterior Lateral Back 16W x 20H
Published
2023-05-30
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
KNNCOMPONENTS, WHEELCHAIR

Product Code Classifications

CodeDeviceSpecialtyClass
KNNComponents, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850013379224PreviousGS10
00840363300481PrimaryGS10

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Length20Inch

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
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 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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