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
00816305024531	K203178	000
00816305024807	K203178	000
00816305024814	K203178	000
00816305024821	K203178	000
00816305024517	K203178	000
00816305023763	K203178	000
00816305023770	K203178	000
00816305023787	K203178	000
00816305023794	K203178	000
00816305023800	K203178	000
00816305023817	K203178	000
00816305023824	K203178	000
00816305023831	K203178	000
00816305023848	K203178	000
00816305023855	K203178	000
00816305024791	K203178	000
00816305024784	K203178	000
00816305024548	K203178	000
00816305024555	K203178	000
00816305024562	K203178	000
00816305024579	K203178	000
00816305024586	K203178	000
00816305024609	K203178	000
00816305024616	K203178	000
00816305024623	K203178	000
00816305024630	K203178	000
00816305024739	K203178	000
00816305024746	K203178	000
00816305024753	K203178	000
00816305024760	K203178	000
00816305024777	K203178	000
00816305023862	K203178	000
00816305023879	K203178	000
00816305023886	K203178	000
00816305024197	K203178	000
00816305024203	K203178	000
00816305024210	K203178	000
00816305024227	K203178	000
00816305024234	K203178	000
00816305024241	K203178	000
00816305024258	K203178	000
00816305024265	K203178	000
00816305024272	K203178	000
00816305024289	K203178	000
00816305024296	K203178	000
00816305024302	K203178	000
00816305024319	K203178	000
00816305024326	K203178	000
00816305024180	K203178	000
00816305024173	K203178	000
00816305023893	K203178	000
00816305023909	K203178	000
00816305023916	K203178	000
00816305023923	K203178	000
00816305023930	K203178	000
00816305023947	K203178	000
00816305023954	K203178	000
00816305023961	K203178	000
00816305023978	K203178	000
10816305024057	K203178	000
00816305024135	K203178	000
00816305024142	K203178	000
00816305024159	K203178	000
00816305024166	K203178	000
00816305024333	K203178	000