510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220454Substantially Equivalent

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

Avation Medical, Columbus OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220454 is the FDA 510(k) clearance record for Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application, a class II device, cleared for Avation Medical, Inc. on under FDA product code NAM (Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence). FDA records list one 510(k) clearance for Avation Medical, Inc. As of , FDA records show no recalls naming K220454.

Clearance record

Decision date
Received
(410 days to decision)
Product code
NAM Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
Regulation
21 CFR 876.5310
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Avation Medical, Inc. 1375 Perry St., Columbus OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NAM

Trailing 12 months

FDA records hold no clearances under product code NAM in the trailing twelve months.

FDA records show no clearances under product code NAM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NAM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260