# K013061: Biotouch Massage Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Tactile Systems Technology, Inc.
- Decided: Jul 1, 2002 after 293 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914774 (1992). 1 ancestor in all.
30 later devices descend from it; 5 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914774: Multipulse Sequential Compression Unit, Talley Group, Ltd. (1992) Summary page 2.

## Most influential descendants
- K080134: Compressible Limb and Circulation Therapy System, Model WHF-314 (Power-Q1000) (2009), 14 descendants of its own
- K100656: Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus) (2010), 13 descendants of its own
- K062818: Flexitouch System (2006), 10 descendants of its own
- K120972: Flexitouch System (2012), 9 descendants of its own
- K153311: Flexitouch System (2016), 8 descendants of its own

## Indications for use
The biofouchTMdevice is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as: Primary lymphedema Post mastectomy edema Edema following trauma and sport injuries Post immobilization edema Venous insufficiencies Lymphedema.

Source page: https://510kreport.com/device/K013061
Methodology: https://510kreport.com/methodology