# K203178: Flexitouch Plus System

- Pathway: 510(k) (Traditional)
- Applicant: Tactile Systems Technology, Inc. (Dba Tactile Medical)
- Decided: Dec 20, 2020 after 55 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: 8 generations back to K944567 (1995). 18 ancestors in all.
5 later devices descend from it; 3 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)
- K170216: Flexitouch System, Tactile Systems Technology, Inc. (Dba Tactile Medical) (2017) Summary page 4.
- K182003: Lympha Press Optimal Plus, Mego Afek AC, Ltd. (2019) Summary page 4.

## Most influential descendants
- 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
- K222823: AeroDVx Arm System (2023), 0 descendants of its own
- K212287: Dayspring Lite (2021), 0 descendants of its own

## Indications for use
The Flexitouch Plus Systems and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in 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 - Lipedema - Phlebolymphedema 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/K203178
Methodology: https://510kreport.com/methodology