INNOVO

Cutaneous Electrode Stimulator For Urinary Incontinence

Atlantic Therapeutics Ltd.

The following data is part of a premarket notification filed by Atlantic Therapeutics Ltd. with the FDA for Innovo.

Pre-market Notification Details

• Device ID: K192357
• 510k Number: K192357
• Device Name: INNOVO
• Classification: Cutaneous Electrode Stimulator For Urinary Incontinence
• Applicant: Atlantic Therapeutics Ltd. Parkmore Business Park West Galway, IE H91 Nht7
• Contact: Anne-marie Keenan
• Correspondent: Anne-marie Keenan; Atlantic Therapeutics Ltd. Parkmore Business Park West Galway, IE H91 Nht7
• Product Code: QAJ
• CFR Regulation Number: 876.5330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-29
• Decision Date: 2020-01-16