Scooter

Vehicle, Motorized 3-wheeled

Tianjin Kepler Vehicle Industry Co. Ltd.

The following data is part of a premarket notification filed by Tianjin Kepler Vehicle Industry Co. Ltd. with the FDA for Scooter.

Pre-market Notification Details

• Device ID: K182471
• 510k Number: K182471
• Device Name: Scooter
• Classification: Vehicle, Motorized 3-wheeled
• Applicant: Tianjin Kepler Vehicle Industry Co. Ltd. Xinmin Road, West Area Of Economic And Technological Development Zone Tian Jin, CN 300462
• Contact: Chunxi Zhang
• Correspondent: Ray Wang; Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, CN 102401
• Product Code: INI
• CFR Regulation Number: 890.3800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-09-10
• Decision Date: 2019-07-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06974007070059	K182471	000
00835246009995	K182471	000
00835246009988	K182471	000
00835246009971	K182471	000
00835246009964	K182471	000