Zephyr Technology Corporation
United StatesFDA 510(k) applicant, unverified
- Devices
- 21
What Zephyr Technology Corporation makes
Zephyr Technology Corporation manufactures wearable physiological monitoring devices, including the BioHarness chest strap for real-time biometric data collection and the Biomodule 3-M1 for processing and analyzing physiological signals. These devices are designed to track metrics such as heart rate, respiration, and activity levels for clinical and research applications.
The company’s products fall under FDA Class II regulatory classification and are authorised through the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) registry, adhering to US medical device regulations.
Catalogue
Search and filter all 21 devicesFrequently asked questions
How many devices does Zephyr Technology Corporation have in the registry?
The registry currently lists 21 devices for Zephyr Technology Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zephyr Technology Corporation's devices?
Among its 21 most recently registered devices, Zephyr Technology Corporation has devices listed in FDA 510(k) (4 devices) and FDA GUDID (17 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Zephyr Technology Corporation's devices fall under?
Among its 21 most recently registered devices, the classes recorded for Zephyr Technology Corporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zephyr Technology Corporation in the registry?
The most recently registered devices listed for Zephyr Technology Corporation include ZephyrLIFE Home 9607.0242, Zephyr 9607-0215, ZephyrLIFE Home 9607.0259 and Zephyr BIOMODULE HOLDER.