The following data is part of a premarket notification filed by Shanghai Phoenix Medical Equipment Co., Ltd. with the FDA for Shanghai Phoenix Mechanical Wheelchair.
| Device ID | K130848 |
| 510k Number | K130848 |
| Device Name: | SHANGHAI PHOENIX MECHANICAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | SHANGHAI PHOENIX MEDICAL EQUIPMENT CO., LTD. No.188, Zhongfa Road Zhujing Industrial Park Jinshan District, Shanghai, CN 201500 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen SHANGHAI PHOENIX MEDICAL EQUIPMENT CO., LTD. No.188, Zhongfa Road Zhujing Industrial Park Jinshan District, Shanghai, CN 201500 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-26 |
| Decision Date | 2013-11-12 |
| Summary: | summary |