Clearance Summary
MODIFICATION TO HANDMASTER received FDA 510(k) clearance under submission number K012823, 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 2001-11-14.
- Submission: K012823
- 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: 2001-11-14
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.