Nerivio— 510(k) K223169

Substantially Equivalent

Theranica Bioelectronics , Ltd.

FDA 510(k) clearance K223169 for Nerivio, Substantially Equivalent on 2023-02-06. Applicant: Theranica Bioelectronics , Ltd.. Device class: 2.

Clearance details

Applicant: Theranica Bioelectronics , Ltd.
Product code: Code QGT
Device class: Class 2
Regulation: 21 CFR 882.5899
Advisory panel: Neurology
Date received: 2022-10-11
Decision date: 2023-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.