Flexitouch 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 System.

Pre-market Notification Details

• Device ID: K170216
• 510k Number: K170216
• Device Name: Flexitouch System
• Classification: Sleeve, Limb, Compressible
• Applicant: Tactile Systems Technology, Inc (dba Tactile Medical) 1331 Tyler Street NE, Suite 200 Minneapolis, MN 55413
• Contact: Thomas A. Dold
• Correspondent: Thomas A. Dold; Tactile Systems Technology, Inc (dba Tactile Medical) 1331 Tyler Street NE, Suite 200 Minneapolis, MN 55413
• Product Code: JOW
• CFR Regulation Number: 870.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-01-24
• Decision Date: 2017-05-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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