ZIDA Wearable Neuromodulation System— 510(k) K192731
Substantially EquivalentExodus Innovations
FDA 510(k) clearance K192731 for ZIDA Wearable Neuromodulation System, Substantially Equivalent on 2021-03-19. Applicant: Exodus Innovations. Device class: 2.
Clearance details
- Applicant
- Exodus Innovations
- Product code
- Code NAM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5310
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sufa, IL
Recent devices under product code NAM
view all- K220454 — Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
- K132561 — NURO NEUROMODULATION SYSTEM
- K101847 — URGENT PC STIMULATOR; URGENT PC LEAD SET
- K071822 — URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12
- K061333 — URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12
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.