Clearance Summary
FD TENS 2070 received FDA 510(k) clearance under submission number K111654, 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 2012-03-01.
- Submission: K111654
- Applicant / Sponsor: Fuji Dynamics , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2012-03-01
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.