The following data is part of a premarket notification filed by Jiangsu Horizon Medical Science & Technology Co., Ltd. with the FDA for Manual Wheelchair Sivfh2a102.
| Device ID | K190534 |
| 510k Number | K190534 |
| Device Name: | Manual Wheelchair SIVFH2A102 |
| Classification | Wheelchair, Mechanical |
| Applicant | Jiangsu Horizon Medical Science & Technology Co., Ltd. No.1 Guanhe Road Situ Town, Danyang City, CN 212331 |
| Contact | Cheng Gong |
| 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 | 2019-03-04 |
| Decision Date | 2019-05-29 |