The following data is part of a premarket notification filed by Shanghai Ruike Sports Goods Co., Ltd. with the FDA for Ruike 3421 Powered Wheelchair.
| Device ID | K070501 |
| 510k Number | K070501 |
| Device Name: | RUIKE 3421 POWERED WHEELCHAIR |
| Classification | Wheelchair, Powered |
| 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 | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-21 |
| Decision Date | 2007-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853223008106 | K070501 | 000 |
| 06970765970051 | K070501 | 000 |
| 06970765970914 | K070501 | 000 |
| 00860008903693 | K070501 | 000 |
| 00860008903686 | K070501 | 000 |
| 00860008903617 | K070501 | 000 |
| 00860008903600 | K070501 | 000 |
| 00860008903624 | K070501 | 000 |
| 06970765972239 | K070501 | 000 |