INCONTROL

Stimulator, Electrical, Non-implantable, For Incontinence

INCONTROL MEDICAL, LLC

The following data is part of a premarket notification filed by Incontrol Medical, Llc with the FDA for Incontrol.

Pre-market Notification Details

• Device ID: K110179
• 510k Number: K110179
• Device Name: INCONTROL
• Classification: Stimulator, Electrical, Non-implantable, For Incontinence
• Applicant: INCONTROL MEDICAL, LLC 12715 FALCON DRIVE Brookfield, WI 53005
• Contact: Michael Leigh
• Correspondent: Michael Leigh; INCONTROL MEDICAL, LLC 12715 FALCON DRIVE Brookfield, WI 53005
• Product Code: KPI
• CFR Regulation Number: 876.5320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-01-21
• Decision Date: 2012-02-22
• Summary: summary