Wak-Utah
Country not established
- Devices
- 1
What Wak-Utah makes
Wak-Utah manufactures wearable artificial kidney devices designed to provide continuous renal support for patients with end-stage kidney disease. These devices are intended for use outside of clinical settings, offering an alternative to traditional dialysis therapies.
The company’s wearable artificial kidney is classified as a Class II medical device in the US and has undergone the 510(k) premarket notification process. The device is listed with the FDA under this regulatory pathway. Wak-Utah is headquartered in the United States.
Catalogue
Wak Wearable Artificial Kidney Ref K830291
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Wak-Utah have in the registry?
The registry currently lists 1 device for Wak-Utah. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wak-Utah's devices?
Among its 1 most recently registered device, Wak-Utah has devices listed in FDA 510(k) (1 device).
What risk classes do Wak-Utah's devices fall under?
Among its 1 most recently registered device, the classes recorded for Wak-Utah's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Wak-Utah in the registry?
The most recently registered devices listed for Wak-Utah include WAK WEARABLE ARTIFICIAL KIDNEY.