Clearance Summary
Pulsed electromagnetic field wrap received FDA 510(k) clearance under submission number K202337, sponsored by Hi-Dow International, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2020-12-15.
- Submission: K202337
- Applicant / Sponsor: Hi-Dow International, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5290
- Decision date: 2020-12-15
Classification & Regulation
This clearance is catalogued under FDA product code ILX and 21 CFR 890.5290, within the Physical Medicine review panel as a Class II device.