DEVICE: Axiom (00840363369167)

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Device Record History
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Device Identifier (DI) Information
Axiom
Lateral Trunk Support
In Commercial Distribution
PBLALSS4X5PL
KI MOBILITY, LLC
00840363369167
GS1

1
609305656 *Terms of Use
4 x 5 Curved Lateral Pads with Adjustable Link Swing Away Swivel Pad Mount Hardware - Left (E0956, E1034)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45887 Wheelchair head/trunk support, prefabricated
A prefabricated (non-customized) padded and contoured device designed to attach to the back/seat of a wheelchair to provide the wheelchair occupant with head and trunk postural support and comfort. It may include armrests, a cushioned seat, a belt/harness, thigh support, and/or a tray table. It might additionally be designed for use as a car seat to provide support in vehicles during transportation. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KNO ACCESSORIES, WHEELCHAIR
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
b83ff269-7633-4191-b333-50770718e9c8
March 27, 2026
3
August 29, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)981-1540
sales@kimobility.com
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