The following data is part of a premarket notification filed by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. with the FDA for Yuyue K2 Wheelchair, Yuyue K4 Wheelchair.
| Device ID | K120526 |
| 510k Number | K120526 |
| Device Name: | YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. 333 PFINGSTEN ROAD Northbrook, IL 60062 |
| Contact | Ned Devine |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-02-22 |
| Decision Date | 2012-03-08 |
| Summary: | summary |