Innuovo

Basic Information

• Brand Name: Innuovo
• Primary DI: 06970765970914
• Version / Model: N5513A-091
• 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: 2020-09-04
• Public Version: 1
• Public Version Date: 2020-09-14
• Public Version Status: New
• Public Device Record Key: 62242a4e-6e72-4a9f-b032-78a633dc5e6d

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: 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
ITI	Wheelchair, Powered	Physical Medicine	890.3860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41538	Wheelchair, power-assisted, attendant/occupant-controlled, collapsible	A wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be manually propelled and steered by the pushing and pulling of handles by an attendant or by the rotation of both rear wheels by the occupant, and when needed, power from an electric motor replaces manual wheel rotation. The device may be disassembled or folded for transport.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970765970914	GS1

Premarket Submissions

Submission Number	Supplement Number
K070501	000