Is this your brand? Sign in to claim ownership.
Sign in to claim this brandiMediSync, Inc.
US
Last updated May 30, 2026
What iMediSync, Inc. makes
iMediSync, Inc. manufactures electroencephalograph (EEG) devices designed for neurological monitoring, including systems like the iSyncWave and iSyncBrain©-C. These products are intended for recording and analyzing brain wave activity, supporting clinical diagnostics and research applications.
The company’s EEG devices fall under FDA Class II regulation and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does iMediSync, Inc. manufacture?
iMediSync, Inc. specializes in electroencephalograph (EEG) devices, which are used to record and analyze brain wave activity. These devices support clinical diagnostics and research by monitoring neurological function. Examples include the iSyncWave and iSyncBrain©-C systems.
Where is iMediSync, Inc. based?
iMediSync, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, particularly in markets where domestic manufacturers may have specific advantages.
Which regulatory registries list iMediSync, Inc.’s devices?
iMediSync, Inc.’s EEG devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These registries track devices that have undergone premarket notification (510(k)) or are assigned a UDI for traceability and compliance purposes.
How are iMediSync, Inc.’s devices classified by regulatory authorities?
iMediSync, Inc.’s EEG devices fall under FDA Class II classification. This classification is assigned based on the level of risk associated with the device, where Class II devices require special controls beyond general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- imedisync.com
- —
- —
- [email protected]
- Phone
- +8215334080
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 694063068
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| iSyncWave | ISW-MUS101 | FDA UDI | Class II | Active |
| iSyncBrain©-C | K222838 | FDA 510(k) | Class II | Active |
| iSyncWave | K220056 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Imedisync Inc. Gangnam-gu Seoul · KR FEI 3023707151