The following data is part of a premarket notification filed by Danyang Sunco Machinery Co., Ltd with the FDA for Sunco Mechanical Wheelchair, Model Skw-9003.
| Device ID | K153328 |
| 510k Number | K153328 |
| Device Name: | SUNCO Mechanical Wheelchair, Model SKW-9003 |
| Classification | Wheelchair, Mechanical |
| Applicant | DANYANG SUNCO MACHINERY CO., LTD TAOJING ROAD, OPTICS INDUSTRIAL PARK, SITU TOWN Danyang City, CN 212300 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min DANYANG SUNCO MACHINERY CO., LTD TAOJING ROAD, OPTICS INDUSTRIAL PARK, SITU TOWN Danyang City, 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 | 2015-11-19 |
| Decision Date | 2016-07-20 |
| Summary: | summary |