Danyang Huayi Medical Supply & Equipment Co, Ltd.
Country not established FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Danyang Huayi Medical Supply & Equipment Co, Ltd. makes
The company manufactures manual wheelchairs, including lightweight models (K-Series) and basic designs (H035), categorized under Class I medical devices. These products include K2, K3, K4, and K7 wheelchair variants, designed for mobility assistance.
The portfolio is regulated under the FDA’s 510(k) pathway as Class I devices and is listed in the US market. The company operates from its base in the United States.
Catalogue
Huayi K-Series Lightweight Wheelchair K3/K4 Ref K091482
Regimes: 510(k) Registry: 510(k)Huayi H035 Basic Wheelchair Ref K080114
Regimes: 510(k) Registry: 510(k)Danyang Huayi K2 And K7 Wheelchairs Ref K080207
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Danyang Huayi Medical Supply & Equipment Co, Ltd DANYANG Jiangsu · CN FEI 3006534178
Frequently asked questions
How many devices does Danyang Huayi Medical Supply & Equipment Co, Ltd. have in the registry?
The registry currently lists 3 devices for Danyang Huayi Medical Supply & Equipment Co, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Danyang Huayi Medical Supply & Equipment Co, Ltd.'s devices?
Among its 3 most recently registered devices, Danyang Huayi Medical Supply & Equipment Co, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Danyang Huayi Medical Supply & Equipment Co, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Danyang Huayi Medical Supply & Equipment Co, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Danyang Huayi Medical Supply & Equipment Co, Ltd. in the registry?
The most recently registered devices listed for Danyang Huayi Medical Supply & Equipment Co, Ltd. include HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4, HUAYI H035 BASIC WHEELCHAIR and DANYANG HUAYI K2 AND K7 WHEELCHAIRS.
Which FDA establishments are linked to Danyang Huayi Medical Supply & Equipment Co, Ltd.?
1 FDA establishment is linked to Danyang Huayi Medical Supply & Equipment Co, Ltd. in the registry; they are listed on the company page.