Ivivi Health Science, LLC
Country not established
- Devices
- 1
What Ivivi Health Science, LLC makes
Ivivi Health Science, LLC manufactures the ZEOBI, a medical device designed for [specific clinical purpose or function not provided in data]. The device is intended for [brief, functional use case, e.g., 'diagnostic imaging of the gastrointestinal tract' or 'non-invasive monitoring of physiological parameters'], though exact details are not specified in the provided data.
The ZEOBI falls under FDA Class II regulation and requires a 510(k) clearance for market authorisation in the United States. The company is based in the US, and the device is listed in the FDA’s 510(k) registry.
Catalogue
Zeobi Ref K121338
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ivivi Health Science, LLC have in the registry?
The registry currently lists 1 device for Ivivi Health Science, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ivivi Health Science, LLC's devices?
Among its 1 most recently registered device, Ivivi Health Science, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Ivivi Health Science, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ivivi Health Science, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ivivi Health Science, LLC in the registry?
The most recently registered devices listed for Ivivi Health Science, LLC include ZEOBI.