The following data is part of a premarket notification filed by Danyang Suntec Auto Parts Co., Ltd. with the FDA for Suntec Mechanical Wheelchair, Model St-wl-1000.
| Device ID | K152878 |
| 510k Number | K152878 |
| Device Name: | SUNTEC Mechanical Wheelchair, Model ST-WL-1000 |
| Classification | Wheelchair, Mechanical |
| Applicant | DANYANG SUNTEC AUTO PARTS CO., LTD. JIEPAI INDUSTRIAL ZONE, JIEPAI, DANYANG Zhenjiang, CN 212300 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min DANYANG SUNTEC AUTO PARTS CO., LTD. JIEPAI INDUSTRIAL ZONE, JIEPAI, DANYANG Zhenjiang, CN 212300 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-30 |
| Decision Date | 2016-02-03 |
| Summary: | summary |