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 |