Clearance Summary
CP Relief Wand-OTC received FDA 510(k) clearance under submission number K162630, sponsored by Mid-America Medical Innovations, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2016-12-20.
- Submission: K162630
- Applicant / Sponsor: Mid-America Medical Innovations, LLC
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2016-12-20
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.