FDA.reportPublic FDA data

510(k) K253285

Device
Elitone for Men
Applicant
Elidah, Inc.
510(k) number
K253285
Product code
QAJ
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-23
Date received
2025-09-29
Regulation
876.5330
Classification name
Cutaneous Electrode Stimulator For Urinary Incontinence
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Gloria Kolb
Address
31 Pecks Ln. Suite 11 Newtown CT US 06470 06470

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QAJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K223884ELITONE Urge Urinary Incontinence DeviceElidah, Inc.2023-02-24
K192357INNOVOAtlantic Therapeutics, Ltd.2020-01-16
K183585Elitone DeviceElidah, Inc.2019-02-11
DEN170049InnovoBio-Medical Research, Ltd.2018-11-06