Tactile Medical - FDA 510(k) Cleared Devices

Tactile Medical, develops at-home therapy devices for chronic swelling conditions. The company specializes in pneumatic compression systems treating lymphedema and chronic venous insufficiency. Headquartered in Minneapolis, Minnesota, Tactile Medical combines innovative devices with personalized patient support and reimbursement expertise.

The company has received 2 FDA 510(k) clearances from 2 total submissions. Tactile Medical's cleared devices span anesthesiology and cardiovascular categories, with first clearance in 2024 and most recent clearance in 2026. The company remains actively engaged in regulatory submissions and product development.

Tactile Medical's product portfolio includes advanced pneumatic compression systems designed for head and neck, upper body, and lower body treatment. The company serves tens of thousands of patients annually through its nationwide team of clinical specialists and patient education consultants. Clinical evidence supporting the company's devices includes studies involving more than 1,800 patients.

Explore the company's complete FDA 510(k) clearance history, device names, product codes, and clearance dates in the regulatory database.

510(k) submissions have been managed by DuVal & Associates, P.A. as regulatory consultant.