AccessGUDID - DEVICE: Leckey MyWay Size 2 (05059804173026)

GUDID

Device Identifier (DI) Information

Brand Name: Leckey MyWay Size 2
Version or Model: MyWay Size 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SUNRISE MEDICAL (US) LLC

Primary DI Number: 05059804173026
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962525056 *Terms of Use

Device Description: The supportive gait training walker for children which is all about providing children with maximum opportunities for interaction, exploration and participation in a supported, upright 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":	Yes
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?
66307	Hands-free disability-assistive walker	A non-powered wheeled mobility aid in the form of a non-foldable framework with legs designed to provide a stable hands-free support for a patient with a walking disability (e.g., due to cerebral palsy) or a geriatric/infirm patient when standing or ambulating. It is made of sturdy but lightweight materials in the shape of a mobile support structure with a rear-support mechanism which provides weight-bearing from the back of the patient (e.g., straps around the back and abdominopelvic area).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITJ	Walker, Mechanical

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: 8c5cbf4a-0e70-4e8f-87de-64a0247a51fa
Public Version Date: May 20, 2025
Public Version Number: 2
DI Record Publish Date: September 25, 2023