Accumed Healthcare (Shanghai), Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Accumed Healthcare (Shanghai), Inc. makes
Accumed Healthcare (Shanghai), Inc. manufactures automated blood pressure monitors, including models designed for the upper arm and wrist. These devices are intended for home or clinical use to measure systolic and diastolic blood pressure, typically featuring digital displays and memory functions for tracking readings.
The company’s products are regulated as Class II medical devices under the FDA’s 510(k) clearance pathway. The devices are listed in the FDA’s 510(k) database, adhering to U.S. regulatory standards for automated blood pressure measurement. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Accumed Wrist Automatic Blood Pressure Monitor Ref K112270
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Accumed Healthcare (Shanghai), Inc. have in the registry?
The registry currently lists 2 devices for Accumed Healthcare (Shanghai), Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Accumed Healthcare (Shanghai), Inc.'s devices?
Among its 2 most recently registered devices, Accumed Healthcare (Shanghai), Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Accumed Healthcare (Shanghai), Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Accumed Healthcare (Shanghai), Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Accumed Healthcare (Shanghai), Inc. in the registry?
The most recently registered devices listed for Accumed Healthcare (Shanghai), Inc. include ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR and ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR.