Clearance Summary
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 received FDA 510(k) clearance under submission number K221384, sponsored by Hivox Biotek, 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 2022-06-11.
- Submission: K221384
- Applicant / Sponsor: Hivox Biotek, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2022-06-11
Classification & Regulation
This clearance is catalogued under FDA product code NUH and 21 CFR 882.5890, within the Neurology review panel as a Class II device.