# Tactile Systems Technology, Inc.

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 5 (2002–2015): 5 510(k) clearances
- Product codes: JOW (4), IRP (1)
- Predicates its devices cite: 10 (3 its own); citations of its devices by later devices: 13 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Devon Medical, Inc.: 2 (https://510kreport.com/company/devon-medical)
- Mego Afek AC, Ltd.: 1 (https://510kreport.com/company/mego-afek-ac)
- Talley Group, Ltd.: 1 (https://510kreport.com/company/talley-group)
- Bio Compression Systems, Inc.: 1 (https://510kreport.com/company/bio-compression-systems)
- Medical Compression Systems (Dbn), Ltd.: 1 (https://510kreport.com/company/medical-compression-systems-dbn)
- Jobst Institute, Inc.: 1 (https://510kreport.com/company/jobst-institute)

## Firms that cite its devices most
- Tactile Systems Technology, Inc. (Dba Tactile Medical): 3 (https://510kreport.com/company/tactile-systems-technology-dba-tactile-medical)
- Koya Medical, Inc.: 1 (https://510kreport.com/company/koya-medical)
- Tactile Medical: 1 (https://510kreport.com/company/tactile-medical)
- Lpg One, Inc.: 1 (https://510kreport.com/company/lpg-one)
- Inova Labs, Inc.: 1 (https://510kreport.com/company/inova-labs)
- Wonjin Mulsan Co., Ltd.: 1 (https://510kreport.com/company/wonjin-mulsan)
- Manamed, Inc.: 1 (https://510kreport.com/company/manamed)
- Evolym, LLC: 1 (https://510kreport.com/company/evolym)

## Its most-cited devices
- K013061: Biotouch Massage Therapy System (2002), cited by 5
- K143185: entré Model PD08-U (2015), cited by 4
- K062818: Flexitouch System (2006), cited by 2
- K131193: Actitouch Act-Adaptive Compression Therapy System (2013), cited by 1
- K120972: Flexitouch System (2012), cited by 1

## Recent decisions
- K143185: entré Model PD08-U (May 7, 2015)
- K131193: Actitouch Act-Adaptive Compression Therapy System (Jun 18, 2013)
- K120972: Flexitouch System (Apr 13, 2012)
- K062818: Flexitouch System (Oct 6, 2006)
- K013061: Biotouch Massage Therapy System (Jul 1, 2002)

Source page: https://510kreport.com/company/tactile-systems-technology