AccessGUDID - DEVICE: Mobility scooter (06970765970006)

GUDID

Device Identifier (DI) Information

Brand Name: Mobility scooter
Version or Model: W3331
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zhejiang Innuovo Rehabilitation Devices Co., Ltd

Primary DI Number: 06970765970006
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544392592 *Terms of Use

Device Description: No description.

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INI	Vehicle, Motorized 3-Wheeled

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062676	000

Device Exempt from Premarket Submission: No 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: 087e1f11-5558-4363-b9a2-242178c578a5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 31, 2016