Clearance Summary
LL TENS 160A, LL TENS 160B received FDA 510(k) clearance under submission number K152374, sponsored by Fuji Dynamics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2016-01-13.
- Submission: K152374
- Applicant / Sponsor: Fuji Dynamics , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2016-01-13
Classification & Regulation
This clearance is catalogued under FDA product code NUH and 21 CFR 882.5890, within the Neurology review panel as a Class II device.