Clearance Summary
Hi-Dow Wireless TENS/EMS System (Model HD-5N) received FDA 510(k) clearance under submission number K163393, sponsored by Hi-Dow International, Inc.. 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: K163393
- Applicant / Sponsor: Hi-Dow International, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2017-08-04
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.