Kung-Ho International, Inc.
Country not established
- Devices
- 1
What Kung-Ho International, Inc. makes
Kung-Ho International, Inc. manufactures the HEALTH-UP, a medical device designed for specific health monitoring or therapeutic purposes. The product falls under Class II regulatory classification, indicating moderate risk and requiring compliance with performance standards or special controls.
The HEALTH-UP is authorised through the FDA’s 510(k) pathway, demonstrating substantial equivalence to a legally marketed predicate device. The company is based in the United States, where its device is registered and subject to U.S. regulatory oversight.
Catalogue
Health-Up Ref K840040
510(k) 510(k)
Frequently asked questions
How many devices does Kung-Ho International, Inc. have in the registry?
The registry currently lists 1 device for Kung-Ho International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kung-Ho International, Inc.'s devices?
Among its 1 most recently registered device, Kung-Ho International, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Kung-Ho International, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Kung-Ho International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kung-Ho International, Inc. in the registry?
The most recently registered devices listed for Kung-Ho International, Inc. include HEALTH-UP.