Clearance Summary
FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION received FDA 510(k) clearance under submission number K083441, sponsored by Motion Medical Products, 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 2009-05-22.
- Submission: K083441
- Applicant / Sponsor: Motion Medical Products, LLC
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2009-05-22
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.