AccessGUDID - DEVICE: Eccentric Knee Bolster (07540147002145)

GUDID

Device Identifier (DI) Information

Brand Name: Eccentric Knee Bolster
Version or Model: D-0223-0227-EKB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EKB
Company Name: Motion Concepts Inc

Primary DI Number: 07540147002145
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 259777209 *Terms of Use

Device Description: The Eccentric Knee Bolster is designed for use with MC Modular Power Standing Systems. The eccentric bolster allows for independent adjustment of the left and right knee bolster pads to provide maximum comfort/support for the end user when the wheelchair system is in a standing position.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37744	Wheelchair bracket/mount	A device designed to be attached to a wheelchair to mount a portable accessory (e.g., holder, bag) [not included], as part of wheelchair adaption/customization. It may be in the form of e.g., a rack, adaptor, or clamp.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNN	Components, Wheelchair

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d950cd4a-ec97-4b85-a39c-1aef6873970d
Public Version Date: March 18, 2025
Public Version Number: 2
DI Record Publish Date: December 08, 2022