Flexitouch Plus System

Sleeve, Limb, Compressible

Tactile Systems Technology, Inc. (DBA Tactile Medical)

The following data is part of a premarket notification filed by Tactile Systems Technology, Inc. (dba Tactile Medical) with the FDA for Flexitouch Plus System.

Pre-market Notification Details

• Device ID: K203178
• 510k Number: K203178
• Device Name: Flexitouch Plus System
• Classification: Sleeve, Limb, Compressible
• Applicant: Tactile Systems Technology, Inc. (DBA Tactile Medical) 151 5th Ave NW Suite 100 New Brighton, MN 55112
• Contact: Brett Demchuk
• Correspondent: Lauren Barnes; The Tamarack Group – MPLS, LLC 2584 Upton Avenue South Minneapolis, MN 55405
• Product Code: JOW
• CFR Regulation Number: 870.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-10-26
• Decision Date: 2020-12-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816305025088	K203178	000
00816305024791	K203178	000
00816305024807	K203178	000
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