Rollator

Basic Information

• Brand Name: Rollator
• Primary DI: 06978949461548
• Version / Model: W2301
• Company Name: Zhejiang Innuovo Rehabilitation Devices Co., Ltd
• Labeler DUNS: 544392592
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-13
• Public Version: 1
• Public Version Date: 2025-08-21
• Public Version Status: New
• Public Device Record Key: 34ddc96a-99f2-45c6-91f5-559d93d1154f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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
37951	Handgrip disability-assistive walker, non-powered, foldable	A non-powered, all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and three or four legs designed to provide a stable support for a patient with a walking disability, a geriatric, obese, or infirm patient when standing or ambulating; it may also be used during rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials and in the form of a mobile support structure which the patient holds and pushes in front of them as they walk. It is foldable for storage and transportation and may include a braking mechanism; it may be width-adjustable and some types may include a seat on which the patient can rest.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06978949461548	GS1