Name: Predicase
Price: 199 USD

K-number	K220454
Device name	Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
Applicant	Avation Medical, Inc.
Product code	NAM
Device class	Class II
Decision date	Apr 3, 2023
Decision	Substantially Equivalent
Regulation	876.5310

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.