FDA.reportPublic FDA data

AXIOM G

Primary DI
00850013379149
Brand
AXIOM G
Company
KI MOBILITY, LLC
Model
G
Device description
AXIOM CUSHION G
Published
2020-09-21
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
IMPCushion, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840363301402PrimaryGS10
00840363301426PrimaryGS10
00840363301457PrimaryGS10
00840363301471PrimaryGS10
00840363301488PrimaryGS10
00840363301501PrimaryGS10
00840363301525PrimaryGS10
00840363301532PrimaryGS10
00840363301549PrimaryGS10
00840363301600PrimaryGS10
00840363301624PrimaryGS10
00840363301631PrimaryGS10
00840363301648PrimaryGS10
00840363301662PrimaryGS10
00840363301679PrimaryGS10
00840363301686PrimaryGS10
00840363301723PrimaryGS10
00840363301747PrimaryGS10
00840363301754PrimaryGS10
00840363301778PrimaryGS10
00840363301808PrimaryGS10
00840363301846PrimaryGS10
00840363301853PrimaryGS10
00850013379149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840363301402008403633014028403633014020840363301402
00840363301426008403633014268403633014260840363301426
00840363301457008403633014578403633014570840363301457
00840363301471008403633014718403633014710840363301471
00840363301488008403633014888403633014880840363301488
00840363301501008403633015018403633015010840363301501
00840363301525008403633015258403633015250840363301525
00840363301532008403633015328403633015320840363301532
00840363301549008403633015498403633015490840363301549
00840363301600008403633016008403633016000840363301600
00840363301624008403633016248403633016240840363301624
00840363301631008403633016318403633016310840363301631
00840363301648008403633016488403633016480840363301648
00840363301662008403633016628403633016620840363301662
00840363301679008403633016798403633016790840363301679
00840363301686008403633016868403633016860840363301686
00840363301723008403633017238403633017230840363301723
00840363301747008403633017478403633017470840363301747
00840363301754008403633017548403633017540840363301754
00840363301778008403633017788403633017780840363301778
00840363301808008403633018088403633018080840363301808
00840363301846008403633018468403633018460840363301846
00840363301853008403633018538403633018530840363301853
00850013379149008500133791498500133791490850013379149

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair. It may be used to improve posture, provide back and/or side support, compensate for seat height, relieve stress points, and provide pressure alleviation for the buttocks, lumbar region, and the legs, and/or to provide 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
609305656
Device count
1
DM exempt
false
Premarket exempt
false
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
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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