Mobility scooter

Basic Information

• Brand Name: Mobility scooter
• Primary DI: 06970765970013
• Version / Model: W3431
• 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: 2016-12-31
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: e67d486e-2646-4628-be2a-c1f21b31076c

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	890.3800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31138	Assistive three-wheeled moped	A combustion engine, on-road, vehicle with three wheels mounted on a cycle-like frame upon which the user sits astride used to provide a person with a disability with a means of transportation, typically without the attendance of another person, and is designed to be operated by the user. It is typically a standard moped (denoted by the limited engine capacity, e.g., 50cc ? 125cc) with the necessary modifications constructed by a manufacturer who specializes in making such vehicles. This vehicle will enhance the user's independence in short- to medium-range transportation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	06970765970044	GS1		1	In Commercial Distribution
Primary	06970765970013	GS1