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FDA 510(k)

Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application

N.º K: K220454 · 2023-04-03

SolicitanteAvation Medical, Inc.
Fecha de decisión2023-04-03
Código de productoNAM
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application is the device name listed in this FDA 510(k) record. The listed applicant is Avation Medical, Inc.. It received FDA 510(k) clearance on 2023-04-03 under 510(k) number K220454. The device is classified under product code NAM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application?

Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application is a medical device that received FDA 510(k) clearance on 2023-04-03. The listed applicant is Avation Medical, Inc.. The 510(k) number is K220454.

When did Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application receive FDA 510(k) clearance?

Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application received FDA 510(k) clearance on 2023-04-03, under 510(k) number K220454.

Who is the listed applicant for Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application?

The FDA 510(k) record lists Avation Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application?

The FDA product code for Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application is NAM.

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Dispositivos relacionados (Código: NAM)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K192731ZIDA Wearable Neuromodulation SystemExodus Innovations

Fuente oficial

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