# Pneumatic compression pumps for lymphoedema (Flexitouch, Lympha Press, Hydroven)

Source: https://onco.cc/technologies/pneumatic-compression-lymphoedema/  
OnCo record `pneumatic-compression-lymphoedema` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

An inflatable sleeve or garment connected to a pump that squeezes the swollen arm or leg in waves, used at home alongside compression garments to move fluid out of a limb with lymphoedema.

## Summary

These pumps are cleared under FDA product code JOW (sleeve, limb, compressible; 21 CFR 870.5800, class II), which also covers pumps used to prevent blood clots. Lymphoedema models include Tactile Medical's Flexitouch Plus (K203178, 20 December 2020, and an advanced pneumatic compression system cleared on 31 July 2026, K253555), whose indication lists lymphoedema, post-mastectomy oedema and, for a head and neck garment, "head and neck lymphedema"; Tactile's entré (K143185, 7 May 2015); Mego Afek's Lympha Press Optimal Plus (K182003, 27 February 2019); Bio Compression Systems' Sequential Circulator (K261807, 11 September 2026); Huntleigh's Hydroven 12 (K152228, 4 April 2016); Airos Medical's AIROS 8P (K223193, 9 December 2022); and Wright Linear Pump's models 51 and 52 (K071040, 22 May 2007). Pumps are an addition to decongestive therapy and compression garments, which have their own record; this record does not grade the trial evidence.

## Fields

- Kind: Technology
- Status: established
- Last checked: 2026-11-04
- Also known as: Pneumatic compression device; Sequential compression pump; Intermittent pneumatic compression; Lymphoedema pump; Flexitouch; Lympha Press; Hydroven; entré
- Tags: devices-gaps-2026-11
- Principle: Multi-chamber garments inflate in sequence from the far end of the limb towards the trunk at set pressures, then deflate, moving interstitial fluid towards working lymphatics.
- Since: 2007
- Strengths: Home treatment between therapist visits; Head, neck and trunk garments for sites a sleeve cannot reach
- Limitations: An addition to compression and decongestive therapy, not a replacement; Cost and insurer criteria for advanced pumps

## Sources

- FDA product code JOW: compressible limb sleeve: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=JOW
- FDA 510(k) K203178: Flexitouch Plus system (20 December 2020): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203178
- FDA 510(k) K253555: Flexitouch Plus advanced pneumatic compression system (31 July 2026): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253555
- FDA 510(k) K143185: entré (7 May 2015): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K143185
- FDA 510(k) K182003: Lympha Press Optimal Plus (27 February 2019): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182003
- FDA 510(k) K261807: Sequential Circulator (11 September 2026): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261807
- FDA 510(k) K152228: Hydroven 12 (4 April 2016): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152228
- FDA 510(k) K223193: AIROS 8P (9 December 2022): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223193
- FDA 510(k) K071040: Wright models 51 and 52 (22 May 2007): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071040

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/), [Cervical cancer](https://onco.cc/cancers/cervical/), [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/)
- fronts: [Devices & Physical Therapies](https://onco.cc/fronts/devices/), [Supportive Care & Survivorship](https://onco.cc/fronts/supportive-care/)
- technologies: [Compression, decongestive therapy and exercise for lymphoedema](https://onco.cc/technologies/lymphoedema-decongestive-therapy/), [External breast prostheses, mastectomy bras and nipple prostheses](https://onco.cc/technologies/external-breast-prostheses/), [Lymphoedema: catching it early, and the operations for it](https://onco.cc/technologies/lymphoedema-surgery-and-early-detection/), [Measuring lymphoedema: tape, bioimpedance and the quality of life scales](https://onco.cc/technologies/rejuv-measure-lymphoedema/)
- terms: [Lymphoedema after breast cancer treatment](https://onco.cc/terms/breast-cancer-related-lymphoedema/)

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