Clearance Summary
NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS received FDA 510(k) clearance under submission number K131923, sponsored by Techlink International. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2014-07-03.
- Submission: K131923
- Applicant / Sponsor: Techlink International
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5810
- Decision date: 2014-07-03
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.