AccessGUDID - DEVICE: Manual Elevating CM Legrest (with Calf Pads) (07540147002770)

GUDID

Device Identifier (DI) Information

Brand Name: Manual Elevating CM Legrest (with Calf Pads)
Version or Model: D-0232-MEL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MEL
Company Name: Motion Concepts Inc

Primary DI Number: 07540147002770
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 259777209 *Terms of Use

Device Description: Manual Elevating CM Legrest with Calf Pads with self locking ratchet mechanism. Available with Short KTH range (9.5-14.5") or Long KTH range (12-19"). Optional Foot Platform or Independent Foot Plates Wheelchair component designed for use with Motion Concepts power positioning systems.

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?
32982	Wheelchair footrest/legrest	A platform (typically metal with or without a padded vinyl covering) usually mounted on a wheelchair in pairs, and upon which a wheelchair occupant may place the feet/legs for comfort, support, and/or to keep them off of the ground. It typically includes a mounting frame, footrest, and may include a mounted pad(s) to support the calves of the legs; it may be fixed or adjustable.	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: 1af176a0-c89c-4376-bcc9-3dbf34439459
Public Version Date: October 18, 2023
Public Version Number: 2
DI Record Publish Date: October 04, 2023