ZIDA Wearable Neuromodulation System— 510(k) K192731

Substantially Equivalent

Exodus Innovations

FDA 510(k) clearance K192731 for ZIDA Wearable Neuromodulation System, Substantially Equivalent on 2021-03-19. Applicant: Exodus Innovations.

Clearance details

Applicant: Exodus Innovations
Product code: Code NAM
Advisory panel: Gastroenterology, Urology
Date received: 2019-09-27
Decision date: 2021-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sufa, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code NAM

product code NAM

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.