Clearance Summary
MODIFICATION TO:NESS L300 received FDA 510(k) clearance under submission number K080219, sponsored by Ness-Neuromuscular Electrical Stimulation Systems. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2008-02-28.
- Submission: K080219
- Applicant / Sponsor: Ness-Neuromuscular Electrical Stimulation Systems
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5810
- Decision date: 2008-02-28
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.