← Back to catalogue

Nerivio +1 more model

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K241756

by Theranica Bio-Electronics, Ltd.

Identifiers

510(k) Number
K241756 FDA 510(k)
FDA Product Code
QGT FDA 510(k)
Models / Variants
Nerivio FDA 510(k)EUDAMED
NerivioInfinity FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5899 FDA 510(k)
Regulation Number
882.5899 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Nerivio; Nerivio Infinity is a distal transcutaneous electrical stimulator designed for the treatment of acute migraine. Classified under the nomenclature for neuromodulation devices, it delivers targeted electrical stimulation to alleviate migraine symptoms through a non-invasive, drug-free approach.

Supplied as a single-use device, Nerivio; Nerivio Infinity is regulated under FDA 510(k) clearance and MDR compliance, with a device classification of Class II. It is intended for use in clinical settings by healthcare professionals, requiring no special storage conditions beyond standard room temperature. The device is authorised under the product code QGT and FEI numbers 3015549449, 3015379717, and 3035454575.

Frequently asked questions

What is the Nerivio; Nerivio Infinity used for in clinical practice?

The Nerivio; Nerivio Infinity is designed specifically for the treatment of acute migraine attacks. It works by delivering targeted, non-invasive electrical stimulation to the distal forearm, providing a drug-free approach to alleviate migraine symptoms. It is classified under neuromodulation devices and intended for use by healthcare professionals in clinical settings.

Is the Nerivio; Nerivio Infinity a reusable device, or is it meant for single-use only?

The Nerivio; Nerivio Infinity is supplied as a single-use device, meaning each unit is intended for one-time use only. This design ensures patient safety and hygiene, as it eliminates the need for reprocessing or reuse.

What storage conditions are required for the Nerivio; Nerivio Infinity?

No special storage conditions are required for the Nerivio; Nerivio Infinity. It can be stored at standard room temperature, making it convenient for clinical settings without the need for refrigeration or controlled environments.

How is the Nerivio; Nerivio Infinity regulated, and what does that mean for its use?

The Nerivio; Nerivio Infinity is regulated under FDA 510(k) clearance and MDR compliance, classified as a Class II device. This means it has undergone a review process to demonstrate substantial equivalence to a predicate device, ensuring its safety and effectiveness for the intended use in acute migraine treatment. The device is also authorized under product code QGT, confirming its regulatory status.

Are there different sizes or models of the Nerivio; Nerivio Infinity, and how do they differ?

The provided data does not specify distinct sizes or models beyond the Nerivio and Nerivio Infinity variants. Both are described as distal transcutaneous electrical stimulators for acute migraine, with no additional differentiation in specifications or features mentioned. Clinicians should confirm compatibility with their patient population based on the manufacturer’s guidelines.

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: Homepage - Theranica, PDF October 08, 2024 ℅ Janice Hogan Partner Hogan Lovells US LLP Trade ..., PDF November 8, 2023 Theranica Bioelectronics ltd ℅ Janice Hogan Partner ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Theranica Bio-Electronics, Ltd.

Sources (2)

  • FDA 510(k) K241756 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026