FDA 510(k), K220454, Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application

510(K) Number: K220454
Device Name: Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
Manufacturer: Manish Vaishya
Device Classification Name: Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
Regulation Number: NAM
Classification Product Code: KXA
Date Received: 02/17/2022
Decision Date: 04/03/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology

3,617 pages (4,967 of 8,584 original pages are fully redacted)