Regulatory & Compliance
Committed to Safety, Quality,
and Transparency
iMediSync is dedicated to maintaining the highest standards of regulatory compliance and product safety. We work closely with regulatory bodies including the FDA, CE, and KFDA to ensure our technologies meet rigorous clinical requirements. Please note that regulatory status varies by product and indication.
Product Clearances & Status
iSyncWave
Medical Device- FDA 510(k) Cleared: Class II Medical Device (K212345)
- CE Mark: Certified for European Market
- Intended Use: Measurement and recording of electrical activity of the brain (EEG).
iSyncBrain
Software as Medical Device- FDA Registered: Clinical Decision Support Software
- KFDA Approved: Class II Medical Device Software
- Note: Not intended for standalone diagnosis. Must be used by qualified professionals.
iSyncHeart
Analysis Module- Status: HRV Analysis Module
- Intended Use: Measurement of Heart Rate Variability parameters.
- Disclaimer: Depression/Anxiety models are for investigational use only.
BrainBoost
Wellness- Classification: General Wellness Device
- Use: Relaxation, focus training, and stress management.
- Note: Not intended to treat or cure any medical condition.
Important Disclaimers
Standards & Security
ISO 13485
Certified Quality Management System for Medical Devices
HIPAA Compliant
Full compliance with US health data privacy regulations
GDPR Ready
Adherence to European data protection standards
Questions about regulatory status?
Our compliance team is here to answer your specific questions regarding intended use and clearances.
Contact Compliance Team