AccessGUDID - DEVICE: WOTURE (B845X3011)

GUDID

Device Identifier (DI) Information

Brand Name: WOTURE
Version or Model: X301
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Intco Medical Industries, Inc.

Primary DI Number: B845X3011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080162537 *Terms of Use

Device Description: This is suitable for a single user with limited mobility. It is suitable for indoor and outdoor use. The purpose of walking devices is to compensate for or at least improve restricted walking ability in users.

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?
16221	Walker tray	A metal or plastic platform designed to be attached to a wheeled walker upon which a user may place objects or perform an activity.	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: 02a814c6-51bc-4660-b6e7-f6222908d08f
Public Version Date: June 23, 2025
Public Version Number: 1
DI Record Publish Date: June 13, 2025