Clearance Summary
Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application received FDA 510(k) clearance under submission number K220454, sponsored by Avation Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2023-04-03.
- Submission: K220454
- Applicant / Sponsor: Avation Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5310
- Decision date: 2023-04-03
Classification & Regulation
This clearance is catalogued under FDA product code NAM and 21 CFR 876.5310, within the Gastroenterology, Urology review panel as a Class II device.