Clearance Summary
PAIN-EEZ received FDA 510(k) clearance under submission number K922690, sponsored by International Center For Nutritional Research. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1992-10-13.
- Submission: K922690
- Applicant / Sponsor: International Center For Nutritional Research
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1992-10-13
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.