Identifiers
- 510(k) Number
- K183110 FDA 510(k)
- FDA Product Code
- NUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Livia is a Class 2 Neurology device with product code NUH. It is substantially equivalent to predicate devices in principles of operation, technology, materials, and indications for use.
Livia was cleared by the FDA through the Traditional 510(k) pathway under K183110, following a 543-day review. The device is manufactured by Lifecare, Ltd., located in Tiberias, Israel.
Frequently asked questions
What is the Livia device used for?
Livia is a Class 2 Neurology device with product code NUH that is substantially equivalent to predicate devices in principles of operation, technology, materials, and indications for use, meaning it performs the same basic function and has similar safety and effectiveness as previously cleared devices in its category.
How was the Livia device cleared for market?
Livia received FDA clearance through the Traditional 510(k) pathway under K183110, following a 543-day review process, and was determined to be substantially equivalent to legally marketed predicate devices based on comparison of design, performance, and intended use.
Who manufactures the Livia device and where is it made?
Livia is manufactured by Lifecare, Ltd., located at Zipori St. 2, Tiberias, Israel, with postal code 1424602, as specified in the device’s authorization and establishment registration details.
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: K183110 FDA 510 (k) - LIVIA | Lifecare , Ltd., PDF 510(K) SUMMARY - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183110 | Class II | Active |
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Manufacturer
- Manufacturer
- Lifecare , Ltd.
Sources (1)
- FDA 510(k) K183110 24 fields · synced Sep 21, 2026