Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5800](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5800) → PPS — Sleeve, Head And Neck, Compressible

# PPS · Sleeve, Head And Neck, Compressible

_Cardiovascular · 21 CFR 870.5800 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/PPS

## Overview

- **Product Code:** PPS
- **Device Name:** Sleeve, Head And Neck, Compressible
- **Regulation:** [21 CFR 870.5800](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5800)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K153311](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/PPS/K153311.md) | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | Sep 14, 2016 | SESE |

## Top Applicants

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

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/PPS](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/PPS)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com