INCONTROL

Perineometer

THOUGHT TECHNOLOGY LTD.

The following data is part of a premarket notification filed by Thought Technology Ltd. with the FDA for Incontrol.

Pre-market Notification Details

• Device ID: K935213
• 510k Number: K935213
• Device Name: INCONTROL
• Classification: Perineometer
• Applicant: THOUGHT TECHNOLOGY LTD. 2180 BELGRAVE AVE. Montreal, Quebec, CA H4a 2l8
• Contact: Hal K Myers
• Correspondent: Hal K Myers; THOUGHT TECHNOLOGY LTD. 2180 BELGRAVE AVE. Montreal, Quebec, CA H4a 2l8
• Product Code: HIR
• CFR Regulation Number: 884.1425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-10-29
• Decision Date: 1995-05-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07540191000067	K935213	000