Identifiers
- 510(k) Number
- K232925 FDA 510(k)
- FDA Product Code
- MYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1735 FDA 510(k)
- Regulation Number
- 876.1735 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Gastric Alimetry System is a non-invasive electrogastrography device designed for mapping gastric electrical activity. Classified as an Electrogastrography System, it records high-resolution electrical signals from the stomach using a wearable adhesive patch. This enables objective assessment of gastric motility and function, aiding in the diagnosis of functional gastric disorders. The system provides real-time data correlation with patient-reported symptoms, facilitating comprehensive gastrointestinal evaluation.
The device is supplied as a reusable system with disposable adhesive patches for patient application. It operates in clinical settings, including gastroenterology and urology, and is intended for single-use per patient session. No MRI safety information is specified, and the system requires proper calibration and storage per manufacturer instructions. Authorized for use in the United States under FDA 510(k) clearance (K232925), it adheres to regulatory standards for Class II medical devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Gastric Alimetry: Clarity for Chronic Gastric Symptoms, About Alimetry, Gastric Alimetryᵀᴹ - The Functional Gut Clinic
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232925 | Class II | Active |
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Manufacturer
- Manufacturer
- Alimetry , Ltd.
Sources (1)
- FDA 510(k) K232925 24 fields · synced Sep 20, 2026