Clearance Summary
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit received FDA 510(k) clearance under submission number K171366, sponsored by Stimwave Technologies Inc., Dba Stimq, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2017-08-04.
- Submission: K171366
- Applicant / Sponsor: Stimwave Technologies Inc., Dba Stimq, LLC
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5870
- Decision date: 2017-08-04
Classification & Regulation
This clearance is catalogued under FDA product code GZF and 21 CFR 882.5870, within the Neurology review panel as a Class II device.