1
/
of
0
FDA 510(k), K220454, Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
FDA 510(k), K220454, Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
Unit price
/
per
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: 02/17/2022
Date Received: 04/03/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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: 02/17/2022
Date Received: 04/03/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Couldn't load pickup availability
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
View full details