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FDA 510(k)

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

K-Number: K220454 · 2023-04-03

ApplicantAvation Medical, Inc.
Decision Date2023-04-03
Product CodeNAM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Avation Medical, Inc.. The 510(k) number is K220454.

When was Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application approved by the FDA?

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

What company makes Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application?

Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application is manufactured by Avation Medical, Inc..

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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Related PubMed Literature

PMID: 41987469 [Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 41702410 FDA 510(k) clearances for chronic pain devices: regulatory trends and safety outcomes from 1976-2025. Expert review of medical devices (2026) PMID: 41443207 Artificial Intelligence in UK Hospital Medicine: From Innovation to Implementation. British journal of hospital medicine (London, England : 2005) (2025) PMID: 40856794 [Translational challenges and clinical potential of artificial intelligence in minimally invasive surgery]. Chirurgie (Heidelberg, Germany) (2025)

Related Devices (Code: NAM)

K192731ZIDA Wearable Neuromodulation SystemExodus Innovations

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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