Zewa, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What Zewa, Inc. makes
Zewa, Inc. manufactures blood pressure monitors, including standalone devices and models that combine blood pressure measurement with body fat analysis. Their pacifier thermometers are designed for infant temperature monitoring. All products are intended for home use and consumer health tracking.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Zewa Mfm-007 Blood Pressure Monitor Ref K041491
510(k) 510(k)Delwa-Star Pacifier Thermometer Ref K952765
510(k) 510(k)Therma-H Ref K921189
510(k) 510(k)- 510(k) 510(k)
Frequently asked questions
How many devices does Zewa, Inc. have in the registry?
The registry currently lists 4 devices for Zewa, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zewa, Inc.'s devices?
Among its 4 most recently registered devices, Zewa, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Zewa, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Zewa, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zewa, Inc. in the registry?
The most recently registered devices listed for Zewa, Inc. include ZEWA MFM-007 BLOOD PRESSURE MONITOR, DELWA-STAR PACIFIER THERMOMETER, THERMA-H and DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR.