Relivion— 510(k) K212106

Substantially Equivalent

Neurolief , Ltd.

FDA 510(k) clearance K212106 for Relivion, Substantially Equivalent on 2021-08-02. Applicant: Neurolief , Ltd..

Clearance details

Applicant: Neurolief , Ltd.
Product code: Code PCC
Advisory panel: Neurology
Date received: 2021-07-06
Decision date: 2021-08-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Netanya, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code PCC

product code PCC

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.