Clearance Summary
HARIKY, MODEL GK-7 received FDA 510(k) clearance under submission number K860772, sponsored by K-Mot, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1986-05-09.
- Submission: K860772
- Applicant / Sponsor: K-Mot, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1986-05-09
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.