# K170216: Flexitouch System

- Pathway: 510(k) (Traditional)
- Applicant: Tactile Systems Technology, Inc. (Dba Tactile Medical)
- Decided: May 26, 2017 after 122 days
- Product code: JOW (Sleeve, Limb, 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: 7 generations back to K944567 (1995). 16 ancestors in all.
7 later devices descend from it; 2 cite 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)
- K153311: Flexitouch System, Tactile Systems Technology, Inc. (Dba Tactile Medical) (2016) Summary page 4.

## Most influential descendants
- 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
- K253555: Flexitouch® Plus Advanced Pneumatic Compression System (2026), 0 descendants 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 insufficiency • 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/K170216
Methodology: https://510kreport.com/methodology