The following data is part of a premarket notification filed by Tzora Active Systems Ltd. with the FDA for Titan 3w.
| Device ID | K160835 |
| 510k Number | K160835 |
| Device Name: | Titan 3W |
| 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. (POB 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 | 2016-03-25 |
| Decision Date | 2017-02-02 |
| Summary: | summary |