The following data is part of a premarket notification filed by Jiangsu Jumao Medical Equipment Co., Ltd. with the FDA for Manual Wheelchair W54.
| Device ID | K180309 |
| 510k Number | K180309 |
| Device Name: | Manual Wheelchair W54 |
| Classification | Wheelchair, Mechanical |
| Applicant | Jiangsu Jumao Medical Equipment Co., Ltd. No.36 Danyan Road Danyang City, CN 212300 |
| Contact | Qian Gao |
| Correspondent | Jinghua Zhou Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, CN 511660 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-02 |
| Decision Date | 2019-05-03 |