# Tactile Medical

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 3 (2024–2026): 3 510(k) clearances
- Product codes: JOW (2), BYI (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 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
- Tactile Systems Technology, Inc.: 1 (https://510kreport.com/company/tactile-systems-technology)
- International Biophysics Corp.: 1 (https://510kreport.com/company/international-biophysics)
- Tactile Systems Technology, Inc. (Dba Tactile Medical): 1 (https://510kreport.com/company/tactile-systems-technology-dba-tactile-medical)
- Koya Medical, Inc.: 1 (https://510kreport.com/company/koya-medical)

## Recent decisions
- K253555: Flexitouch® Plus Advanced Pneumatic Compression System (Jul 31, 2026)
- K252849: AffloVest® Mobile Airway Clearance Therapy (Apr 30, 2026)
- K234155: Nimbl (model PD08-N1) (Jun 21, 2024)

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