510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153311Substantially Equivalent

Flexitouch System

Tactile Systems Technology, Inc. (dba Tactile Medical), Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153311 is the FDA 510(k) clearance record for Flexitouch System, a class II device, cleared for Tactile Systems Technology, Inc. (Dba Tactile Medical) on under FDA product code PPS (Sleeve, Head And Neck, Compressible). FDA's definition for product code PPS reads: "Intended to move excess fluid from the target area to another area of the body". FDA records list 3 510(k) clearances for Tactile Systems Technology, Inc. (Dba Tactile Medical), from to . As of , FDA records show no recalls naming K153311.

Clearance record

Decision date
Received
(302 days to decision)
Product code
PPS Sleeve, Head And Neck, Compressible
Regulation
21 CFR 870.5800
Device class
Class II
Review panel
Cardiovascular
Applicant
Tactile Systems Technology, Inc. (Dba Tactile Medical) 1331 Tyler St. NE, Suite 200, Minneapolis MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PPS

Trailing 12 months

FDA records hold no clearances under product code PPS in the trailing twelve months.

FDA records show no clearances under product code PPS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PPS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260