Ice Neurosystems, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Ice Neurosystems, Inc. makes
Ice Neurosystems, Inc. manufactures subcutaneous electrode kits and arrays, including the iCE-SG2 and iCE-SG models, designed for deep brain stimulation and neuromodulation applications. The company also produces the iCEWav neuromonitoring platform, which supports real-time data acquisition and analysis for clinical use.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
iCE-SG2 Subcutaneous Electrode Kit Ref K222706
Regimes: 510(k) Registry: 510(k)iCE-SG Subcutaneous Electrode Arrays Ref K201678
Regimes: 510(k) Registry: 510(k)iCEWav Neuromonitoring Platform Ref K191868
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ice Neurosystems, Inc. have in the registry?
The registry currently lists 3 devices for Ice Neurosystems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ice Neurosystems, Inc.'s devices?
Among its 3 most recently registered devices, Ice Neurosystems, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Ice Neurosystems, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Ice Neurosystems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ice Neurosystems, Inc. in the registry?
The most recently registered devices listed for Ice Neurosystems, Inc. include iCE-SG2 Subcutaneous Electrode Kit, iCE-SG Subcutaneous Electrode Arrays and iCEWav Neuromonitoring Platform.