Clearance Summary
MINI PATCH received FDA 510(k) clearance under submission number K121353, sponsored by Well-Life Healthcare Limited. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2012-09-07.
- Submission: K121353
- Applicant / Sponsor: Well-Life Healthcare Limited
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2012-09-07
Classification & Regulation
This clearance is catalogued under FDA product code NUH and 21 CFR 882.5890, within the Neurology review panel as a Class II device.