Product code PPS— Cardiovascular

Flexitouch System

Classification name: Sleeve, Head And Neck, Compressible
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Total cleared: 1
First cleared: 2016-09-14
Most recent: 2016-09-14

FDA classification definition

“Intended to move excess fluid from the target area to another area of the body.”
— U.S. Food and Drug Administration, device classification record for product code PPS under 21 CFR 870.5800, via openFDA

Market context for product code PPS

FDA has cleared 1 device under product code PPS, all in 2016, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PPS

Tactile Systems Technology, Inc. (Dba Tactile Medical)1 clearance

Recent clearances under product code PPS

K153311 — Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical)·2016-09-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.