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510(k) K192357

Device
INNOVO
Applicant
Atlantic Therapeutics Ltd.
510(k) number
K192357
Product code
QAJ  
Decision
Substantially Equivalent (SESE)
Decision date
2020-01-16
Date received
2019-08-29
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
No

Applicant Contact#

Contact
Anne-Marie Keenan
Address
Parkmore Business Park W. Galway IE H91NHT7 H91NHT7

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
K253285Elitone for MenElidah, Inc.2026-01-23
K223884ELITONE Urge Urinary Incontinence DeviceElidah, Inc.2023-02-24
K183585Elitone DeviceElidah, Inc.2019-02-11
DEN170049InnovoBio-Medical Research, Ltd.2018-11-06

Legacy Summary#

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FDA Review#

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