Clearance Summary
TENSWave received FDA 510(k) clearance under submission number K241228, sponsored by Zynex Medical Officer. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2024-08-27.
- Submission: K241228
- Applicant / Sponsor: Zynex Medical Officer
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2024-08-27
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.