Clearance Summary
IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2 received FDA 510(k) clearance under submission number K060975, sponsored by Theratech, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2006-05-10.
- Submission: K060975
- Applicant / Sponsor: Theratech, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2006-05-10
Classification & Regulation
This clearance is catalogued under FDA product code LIH and 21 CFR 882.5890, within the Neurology review panel as a Class II device.