Clearance Summary
NeoWave Pain Relief and Recovery System, Model# T16-2020 received FDA 510(k) clearance under submission number K202693, sponsored by Eva Medtec, 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 2021-03-05.
- Submission: K202693
- Applicant / Sponsor: Eva Medtec, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 2021-03-05
Classification & Regulation
This clearance is catalogued under FDA product code IRP and 21 CFR 890.5650, within the Physical Medicine review panel as a Class II device.