Kepler

Basic Information

• Brand Name: Kepler
• Primary DI: 06974007070059
• Version / Model: kpl001
• Company Name: Tianjin Kepler Vehicle Industry Co.,Ltd.
• Labeler DUNS: 554445223
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-30
• Public Version: 1
• Public Version Date: 2023-04-07
• Public Version Status: New
• Public Device Record Key: 6864457d-d0ed-4279-927a-7997c64f658b

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
45684	Assistive scooter, electric-motor-driven	A battery-powered, electric-motor-driven mobility device designed to be operated by a person with a disability and consisting of a seat over two rear wheels, a platform for the feet, and handlebars in front to turn one or two steerable front wheels connected via a steering-column. Commonly referred to as a mobility scooter, it is used to enhance the user's ability for self-transportation in the local environment and/or to promote the user's physical/recreational activities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974007070059	GS1

Premarket Submissions

Submission Number	Supplement Number
K182471	000