The following data is part of a premarket notification filed by Danyang Huayi Medical Supply & Equipment Co, Ltd with the FDA for Huayi H035 Basic Wheelchair.
| Device ID | K080114 |
| 510k Number | K080114 |
| Device Name: | HUAYI H035 BASIC WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD 9109 COPENHAVER DRIVE Potomac, MD 20854 |
| Contact | Norman F Estrin |
| Correspondent | Norman F Estrin DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD 9109 COPENHAVER DRIVE Potomac, MD 20854 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-16 |
| Decision Date | 2008-02-15 |
| Summary: | summary |