Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027578962

FEI Number

3027578962

Entity Name

AVATION MEDICAL

City/State/Country

Columbus, OH, US

Establishment Address

1375 Perry St, Suite 13-150, Columbus, OH 43201, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Avation Medical (Owner Number: 10088188)

Owner / Operator Contact Address

1375 Perry St, Suite 13-150, Columbus, OH 43201, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220454

PMA Number

N/A

All Registered Proprietary Names

Vivally System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAM	Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence	Gastroenterology, Urology	Class 2	876.5310	2023-06-07

Official Correspondent

Manish Vaishya

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Avation Medical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027578962. Last updated year: 2026. Please use registration number 3027578962 when referencing this establishment in official correspondence.