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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 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.

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. 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07772427Neuromodulation During the Prodrome to Prevent Disabling Migraine Attacks in YouthNOT_YET_RECRUITINGNCT06748157Non-Invasive Median Nerve Stimulation to Attenuate Atrial Tachyarrhythmias After Catheter Ablation for Atrial FibrillationACTIVE_NOT_RECRUITINGNCT07206446A Prospective Evaluation of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women: The RiSolve TrialCOMPLETEDNCT07487454Sham-Controlled Rapid-Acting Neuromodulation for DepressionNOT_YET_RECRUITINGNCT07487701Migraine Prevention With the Remote Electrical Neuromodulation (REN) Wearable: A Real-world Evidence StudyCOMPLETEDNCT07571226Identification and Molecular Characterisation of Urban-environmental Stress Patterns Affecting Mental IllnessRECRUITING

Related Devices (Code: NAM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192731ZIDA Wearable Neuromodulation SystemExodus Innovations

Official Source

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

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