Sensacare, Ltd.
TaiwanFDA applicant, unverified
- Devices
- 2
What Sensacare, Ltd. makes
Sensacare, Ltd. manufactures digital blood pressure monitors, including an upper-arm model (SAA-102) and a wrist-mounted model (SAW-102). These devices are designed for home or clinical use to measure systolic and diastolic blood pressure via automated inflation and cuff-based readings.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The devices are listed in the FDA’s 510(k) database, adhering to U.S. regulatory requirements. Sensacare, Ltd. is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sensacare, Ltd. have in the registry?
The registry currently lists 2 devices for Sensacare, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sensacare, Ltd.'s devices?
Among its 2 most recently registered devices, Sensacare, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Sensacare, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sensacare, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sensacare, Ltd. in the registry?
The most recently registered devices listed for Sensacare, Ltd. include SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR and SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR.