Titan

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 Titan.

Pre-market Notification Details

• Device ID: K150086
• 510k Number: K150086
• Device Name: Titan
• 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 Hata'as St.(PO Box 124) 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: 2015-01-15
• Decision Date: 2015-08-05
• Summary: summary