Nerivio— 510(k) K201824

Substantially Equivalent

Theranica Bio-Electronics, Ltd.

FDA 510(k) clearance K201824 for Nerivio, Substantially Equivalent on 2020-10-23. Applicant: Theranica Bio-Electronics, Ltd.. Device class: 2.

Clearance details

Applicant: Theranica Bio-Electronics, Ltd.
Product code: Code QGT
Device class: Class 2
Regulation: 21 CFR 882.5899
Advisory panel: Neurology
Date received: 2020-07-01
Decision date: 2020-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code QGT

K250405 — Nerivio; Nerivio Infinity2025-05-14
K241756 — Nerivio; NerivioInfinity2024-10-08
K232152 — NerivioInfinity2023-11-08
K223169 — Nerivio2023-02-06
K203181 — Nerivio, FGD000075-4.72021-01-22

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