Clearance Summary
Wrap accessory electrodes received FDA 510(k) clearance under submission number K190617, 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 2019-07-02.
- Submission: K190617
- Applicant / Sponsor: Hi-Dow International, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2019-07-02
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.