Nerivio; Nerivio Infinity— 510(k) K250405

Substantially Equivalent

Theranica Bio-Electronics, Ltd.

FDA 510(k) clearance K250405 for Nerivio; Nerivio Infinity, Substantially Equivalent on 2025-05-14. Applicant: Theranica Bio-Electronics, Ltd..

Clearance details

Applicant: Theranica Bio-Electronics, Ltd.
Product code: Code QGT
Advisory panel: Neurology
Date received: 2025-02-13
Decision date: 2025-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

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