Clearance Summary
NESS SYSTEM received FDA 510(k) clearance under submission number K022776, sponsored by Ness-Neuromuscular Electrical Stimulation Systems. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2002-09-11.
- Submission: K022776
- Applicant / Sponsor: Ness-Neuromuscular Electrical Stimulation Systems
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2002-09-11
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.