Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application— 510(k) K220454
Substantially EquivalentAvation Medical, Inc.
FDA 510(k) clearance K220454 for Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application, Substantially Equivalent on 2023-04-03. Applicant: Avation Medical, Inc..
Clearance details
- Applicant
- Avation Medical, Inc.
- Product code
- Code NAM
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbus, OH, US
Adverse events under product code NAM
product code NAM- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.