Kepler

GUDID 06974007070059

Tianjin Kepler Vehicle Industry Co.,Ltd.

Assistive scooter, electric-motor-driven

• Primary Device ID: 06974007070059
• NIH Device Record Key: 6864457d-d0ed-4279-927a-7997c64f658b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kepler
• Version Model Number: kpl001
• Company DUNS: 554445223
• Company Name: Tianjin Kepler Vehicle Industry Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974007070059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182471

FDA Product Code

• INI: Vehicle, Motorized 3-Wheeled

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-07
• Device Publish Date: 2023-03-30