The following data is part of a premarket notification filed by Hansung Econet Co., Ltd. with the FDA for Opti-rider Deluxe.
| Device ID | K033116 |
| 510k Number | K033116 |
| Device Name: | OPTI-RIDER DELUXE |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | HANSUNG ECONET CO., LTD. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia J.m. Nolte |
| Correspondent | Cynthia J.m. Nolte HANSUNG ECONET CO., LTD. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2004-04-12 |
| Summary: | summary |