Clearance Summary
CP RELIEF WAND received FDA 510(k) clearance under submission number K133779, 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 2014-05-30.
- Submission: K133779
- 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: 2014-05-30
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.