Lite

Vehicle, Motorized 3-wheeled

Tzora Active Systems Ltd.

The following data is part of a premarket notification filed by Tzora Active Systems Ltd. with the FDA for Lite.

Pre-market Notification Details

• Device ID: K172409
• 510k Number: K172409
• Device Name: Lite
• Classification: Vehicle, Motorized 3-wheeled
• Applicant: Tzora Active Systems Ltd. Kibbutz Tzora, IL 9980300
• Contact: Adi Shemer
• Correspondent: Moshe Rosenberg; A. Stein Regulatory Affairs Consulting Ltd. 20 Hataas St., Suite 102 Kfar Saba, IL 4442520
• Product Code: INI
• CFR Regulation Number: 890.3800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-09
• Decision Date: 2018-05-02
• Summary: summary