Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

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

Número K: K220454 · 2023-04-03

RequerenteAvation Medical, Inc.
Data da decisão2023-04-03
Código do produtoNAM
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: NAM)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K192731ZIDA Wearable Neuromodulation SystemExodus Innovations

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.

↑