# K062818: Flexitouch System

- Pathway: 510(k) (Traditional)
- Applicant: Tactile Systems Technology, Inc.
- Decided: Oct 6, 2006 after 16 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: 4 generations back to K944567 (1995). 13 ancestors in all.
10 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)
- K043423: Model SC-3008 Sequential Circulator, Bio Compression Systems, Inc. (2005) Summary page 1.
- K060146: Activecare ++ System, Medical Compression Systems (Dbn), Ltd. (2006) Summary page 1.
- K013061: Biotouch Massage Therapy System, Tactile Systems Technology, Inc. (2002) Summary page 1.

## Most influential descendants
- K120972: Flexitouch System (2012), 9 descendants of its own
- K153311: Flexitouch System (2016), 8 descendants of its own
- 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

## Indications for use
The Flexitouch system is intended for use by medical professionals and patients who are under medical supervision, in treating many conditions such as: • Primary lymphedema * Post mastectomy edema * Edema following trauma and sports injuries * Post immobilization edema * Venous insufficiencies * Lymphedema. * Reducing wound healing time * Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers

Source page: https://510kreport.com/device/K062818
Methodology: https://510kreport.com/methodology