AccessGUDID - DEVICE: HEMI SMART LEG ART.LEGS-ALUM (00841447114994)

GUDID

Device Identifier (DI) Information

Brand Name: HEMI SMART LEG ART.LEGS-ALUM
Version or Model: AHL4A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INVACARE CORPORATION

Primary DI Number: 00841447114994
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076916246 *Terms of Use

Device Description: Swing-Away Hemi Smartleg Articulating Legrests, Aluminum Footplates, Padded Calf Pads

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):	Yes
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
IMM	Footrest, 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: 0f971424-034e-478e-baf3-edc5ddf210e1
Public Version Date: August 02, 2024
Public Version Number: 1
DI Record Publish Date: July 25, 2024