The following data is part of a premarket notification filed by Danyang Huayi Medical Supply & Equipment Co, Ltd with the FDA for Huayi K-series Lightweight Wheelchair K3/k4.
| Device ID | K091482 |
| 510k Number | K091482 |
| Device Name: | HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 |
| Classification | Wheelchair, Mechanical |
| Applicant | DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD 3119 BRICK LANE Decatur, GA 30033 |
| Contact | Jiuguang (joe) Song |
| Correspondent | Jiuguang (joe) Song DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD 3119 BRICK LANE Decatur, GA 30033 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-19 |
| Decision Date | 2009-07-06 |
| Summary: | summary |