Clearance Summary
MEDA 2500 T.E.N.S. received FDA 510(k) clearance under submission number K862450, sponsored by Watlow/Winona, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1986-11-25.
- Submission: K862450
- Applicant / Sponsor: Watlow/Winona, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1986-11-25
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.