# K153311: Flexitouch System

- Pathway: 510(k) (Traditional)
- Applicant: Tactile Systems Technology, Inc. (Dba Tactile Medical)
- Decided: Sep 14, 2016 after 302 days
- Product code: PPS (Sleeve, Head And Neck, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K944567 (1995). 15 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120972: Flexitouch System, Tactile Systems Technology, Inc. (2012) Summary page 4.
- K062818: Flexitouch System, Tactile Systems Technology, Inc. (2006) Summary page 4.
- K013061: Biotouch Massage Therapy System, Tactile Systems Technology, Inc. (2002) Summary page 4.

## Most influential descendants
- K170216: Flexitouch System (2017), 7 descendants of its own
- K203178: Flexitouch Plus System (2020), 5 descendants of its own
- K193288: Koya Ripple (2020), 5 descendants of its own
- K210885: Dayspring (2021), 4 descendants of its own
- K223228: Dayspring (2024), 1 descendant of its own

## Indications for use
The Flexitouch® system and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as: • Lymphedema • Primary lymphedema • Post mastectomy edema • Edema following trauma and sports injuries • Post immobilization edema • Venous insufficiencies • Reducing wound healing time • Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers The Flexitouch® system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.

Source page: https://510kreport.com/device/K153311
Methodology: https://510kreport.com/methodology