The following data is part of a premarket notification filed by Shanghai Ruike Sports Goods Co., Ltd. with the FDA for Ruike, Model 3411.
| Device ID | K062646 |
| 510k Number | K062646 |
| Device Name: | RUIKE, MODEL 3411 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | SHANGHAI RUIKE SPORTS GOODS CO., LTD. 14F-2, NO.1, LANE 25 ZHUANGJING RD. Banqiao, Taipei County, TW 220 |
| Contact | Junnata Chang |
| Correspondent | Junnata Chang SHANGHAI RUIKE SPORTS GOODS CO., LTD. 14F-2, NO.1, LANE 25 ZHUANGJING RD. Banqiao, Taipei County, TW 220 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-04 |
| Decision Date | 2007-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970765972222 | K062646 | 000 |
| 06970765972215 | K062646 | 000 |