Clearance Summary
NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT received FDA 510(k) clearance under submission number K111767, sponsored by Ness-Neuromuscular Electrical Stimulation Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2011-09-15.
- Submission: K111767
- Applicant / Sponsor: Ness-Neuromuscular Electrical Stimulation Systems
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5810
- Decision date: 2011-09-15
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.