Handiflex Corp.
Country not established
- Devices
- 1
What Handiflex Corp. makes
Handiflex Corp. manufactures the Handiflex device, a passive dynamic hip joint replacement designed for patients with severe hip arthritis or congenital hip dysplasia. The product is intended to restore mobility and reduce pain by providing a durable, low-friction articulation for hip movement.
The Handiflex device is classified as Class II under FDA regulations and is authorised via the 510(k) clearance process. It is listed in the FDA’s 510(k) database. The company is headquartered in the United States.
Catalogue
Handiflex Ref K971046
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Handiflex Corp. have in the registry?
The registry currently lists 1 device for Handiflex Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Handiflex Corp.'s devices?
Among its 1 most recently registered device, Handiflex Corp. has devices listed in FDA 510(k) (1 device).
What risk classes do Handiflex Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Handiflex Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Handiflex Corp. in the registry?
The most recently registered devices listed for Handiflex Corp. include HANDIFLEX.