Hai Solutions
Country not established
- Devices
- 1
What Hai Solutions makes
Hai Solutions manufactures the QIKCAP System, a medical device designed for rapid, non-invasive blood pressure measurement in clinical and home settings. The system is intended to provide accurate readings for monitoring hypertension and related conditions, supporting both healthcare professionals and patients.
The QIKCAP System is classified as a Class II device under FDA regulations and has undergone 510(k) clearance. The device is listed in the FDA’s 510(k) database, adhering to U.S. medical device compliance standards. The manufacturer operates from the United States.
Catalogue
QIKCAP System Ref DEN250004
Regimes: De Novo Registry: De Novo
Frequently asked questions
How many devices does Hai Solutions have in the registry?
The registry currently lists 1 device for Hai Solutions. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hai Solutions's devices?
Among its 1 most recently registered device, Hai Solutions has devices listed in FDA 510(k) (1 device).
What risk classes do Hai Solutions's devices fall under?
Among its 1 most recently registered device, the classes recorded for Hai Solutions's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hai Solutions in the registry?
The most recently registered devices listed for Hai Solutions include QIKCAP System.