Clearance Summary
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit received FDA 510(k) clearance under submission number K162161, sponsored by Stimwave Technologies Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2016-12-16.
- Submission: K162161
- Applicant / Sponsor: Stimwave Technologies Incorporated
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5880
- Decision date: 2016-12-16
Classification & Regulation
This clearance is catalogued under FDA product code GZB and 21 CFR 882.5880, within the Neurology review panel as a Class II device.