Clearance Summary
FES CYCLE ERGOMETER, MODEL RT300-S received FDA 510(k) clearance under submission number K050036, sponsored by Restorative Therapies, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2005-06-27.
- Submission: K050036
- Applicant / Sponsor: Restorative Therapies, Inc.
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5810
- Decision date: 2005-06-27
Classification & Regulation
This clearance is catalogued under FDA product code GZI and 21 CFR 882.5810, within the Neurology review panel as a Class II device.