The following data is part of a premarket notification filed by Tzora Active Systems Ltd. with the FDA for The Elite - Ultra-light, Compact Portable Scooter.
| Device ID | K052204 |
| 510k Number | K052204 |
| Device Name: | THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | TZORA ACTIVE SYSTEMS LTD. Kibbutz Tzora, IL 99803 |
| Contact | Alex Gonorovsky |
| Correspondent | Alex Gonorovsky TZORA ACTIVE SYSTEMS LTD. Kibbutz Tzora, IL 99803 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-12 |
| Decision Date | 2006-02-15 |
| Summary: | summary |