Fundamental Industrial Co., Ltd.
Hong Kong SAR ChinaFDA 510(k) applicant, unverified
- Devices
- 1
What Fundamental Industrial Co., Ltd. makes
Fundamental Industrial Co., Ltd. manufactures general industrial devices, including the FI series, GORDY TOY, and WELLJOY products, which appear to be Class I medical devices.
These products are regulated under the FDA’s 510(k) pathway as Class I devices and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Fi, Gordy Toy, Welljoy And Others Ref K946004
510(k) 510(k)
Frequently asked questions
How many devices does Fundamental Industrial Co., Ltd. have in the registry?
The registry currently lists 1 device for Fundamental Industrial Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fundamental Industrial Co., Ltd.'s devices?
Among its 1 most recently registered device, Fundamental Industrial Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Fundamental Industrial Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Fundamental Industrial Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Fundamental Industrial Co., Ltd. in the registry?
The most recently registered devices listed for Fundamental Industrial Co., Ltd. include FI, GORDY TOY, WELLJOY AND OTHERS.