WOTURE

Basic Information

• Brand Name: WOTURE
• Primary DI: B845X3011
• Version / Model: X301
• Company Name: Intco Medical Industries, Inc.
• Labeler DUNS: 080162537
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-13
• Public Version: 1
• Public Version Date: 2025-06-23
• Public Version Status: New
• Public Device Record Key: 02a814c6-51bc-4660-b6e7-f6222908d08f

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

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITJ	Walker, Mechanical	Physical Medicine	890.3825	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B845X3013	HIBCC		1	In Commercial Distribution
Primary	B845X3011	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]